bluuebunny/crossref_metadata_2025_split huggingface dataset:
A population-based study of young-onset colorectal cancer patients: Effect of knowledge gaps among patients and providers on stage at diagnosis and quality of life.
Authors: Yarden Ronit , Newcomer Kim Lynn , Peterson Danielle ,   N2Young Advisory Board
Published: May 2020

4095 Background: Colorectal cancer (CRC) is one of the leading cause of cancer-related death in the US. Despite a decrease in overall incidence and mortality, there has been an alarming increase in CRC diagnosis among young adults (20-49 years old) and causes remain unknown. To explore the unique challenges and unmet needs of the young-adult patients many still establishing their life-long goals, the Colorectal Cancer Alliance launched a comprehensive survey for young-onset CRC patients and survivors via social media to track the self-reported pre-diagnosis awareness, path to diagnosis, and post-diagnosis quality of life experiences of this often overlooked group. Methods: A cross-sectional study, conducted in the form of an online survey, was launched via multiple channels of social media. The questionnaire was based on established instruments including PROMIS, EORTC-QOL-30, and EORTC-CR-29 and EORTC-SHC-22. Results: The survey was completed by 885 patients and survivors. The median age at diagnosis was 42 +/-7, significantly lower than the recommended screening age. Only 6% of respondents were diagnosed with Lynch syndrome although 29% reported some family history. Most respondents (63%) indicated they were not aware that CRC can affect people younger than 50, which may explain why the majority of patients waited more than 3 months and 23% waited over 12 months after noticing their symptoms to visit their doctor. The majority, 75%, of all patients visited 2+ doctors and 11% of those patients visited 10+ doctors before their doctor suspected colorectal cancer. A significant number of patients felt their doctors were dismissive of their symptoms. 77% of patients were diagnosed with advanced disease and were subjected to aggressive therapies that substantially affected their quality of life including neuropathy, anxiety, clinical depression, sexual morbidity, unemployment, and financial toxicity. Many young patients indicated that their doctors did not inform them about fertility preservation. Conclusions: Our survey indicates that medical professionals and young adults need to be aware of the increasing incidence of young-onset CRC, and the importance of timely screening when signs and symptoms are present, regardless of age.
Trastuzumab with trimodality treatment for esophageal adenocarcinoma with HER2 overexpression: NRG Oncology/RTOG 1010.
Authors: Safran Howard , Winter Kathryn A. , Wigle Dennis A. , DiPetrillo Thomas A. , Haddock Michael G. , Hong Theodore S. , Leichman Lawrence P. , Rajdev Lakshmi , Resnick Murray B. , Kachnic Lisa A. , Seaward Samantha A. , Mamon Harvey J. , Diaz Pardo Dayssy Alexandra , Anderson Carryn M. , Shen Xinglei , Sharma Anand K. , Katz Alan W. , Salo Jonathan C. , Leonard Kara Lynne , Crane Christopher H. 
Published: May 2020

4500 Background: Trastuzumab is a monoclonal antibody against human epidermal growth factor receptor 2 (HER2). The primary objective of RTOG 1010 was to determine if trastuzumab increases disease-free survival (DFS) when combined with trimodality treatment for patients with HER2 overexpressing esophageal adenocarcinoma. Methods: This open label, randomized phase III trial included patients with newly diagnosed stage T1N1-2, T2-3N0-2 adenocarcinoma of the esophagus involving the mid, distal, or esophagogastric junction and up to 5cm of the stomach. All patients received chemotherapy (C) of paclitaxel, 50mg/m2 and carboplatin AUC = 2, weekly for 6 weeks, with radiation (XRT: 3D-CRT or IMRT, 50.4 Gy in 28 fractions) followed by surgery. Patients were randomized 1:1 to receive weekly trastuzumab 4mg/kg week 1 then 2mg/kg/weekly x 5 during CXRT then 6 mg/kg for 1 dose prior to surgery and 6mg/kg every 3 weeks for 13 treatments after surgery. HER2 status was determined by IHC and gene amplification by FISH. With a 2-sided alpha of 0.05, 162 DFS events provide 90% power to detect a signal for an increase in median DFS from 15 to 25 months. DFS and overall survival (OS) were estimated by the Kaplan-Meier method. and arms were compared using the log rank test. The Cox proportional hazards model was used to analyze treatment effect. Results: 571 patients were entered for assessment of HER2 expression, 203 HER2+ patients randomized. The median follow-up for alive patients is 5.0 years. The estimated 2, 3, and 4-year DFS (95% CI) for the CXRT +trastuzumab arm were 41.8% (31.8%, 51.7%), 34.3% (24.7%, 43.9%), and 33.1% (23.6%, 42.7%), respectively, and for the CXRT arm were 40.0% (30.0%, 49.9%), 33.4% (23.8%, 43.0%), and 30.1% (20.7%, 39.4%), respectively; log-rank p = 0.85. The median DFS time is 19.6 months (13.5-26.2) for the CXRT +trastuzumab arm compared to 14.2 months (10.5-23.0) for the CXRT arm. The hazard ratio (95% CI) comparing the DFS of CXRT+trastuzumab arm to the CXRT arm was 0.97 (0.69, 1.36). The median OS time was 38.5 months (26.2-70.4) for the CXRT+trastuzumab arm compared to 38.9 months (29.0-64.5) for the CXRT arm, hazard ratio (95% CI): 1.01 (0.69, 1.47). There was no statistically significant increase in treatment-related toxicities with the addition of trastuzumab including no increase in cardiac events. Conclusions: The addition of trastuzumab to trimodality treatment did not improve DFS for patients with HER2 overexpressing esophageal adenocarcinoma. Supported by NCI grants U10CA180868, UG1CA189867, U10CA180822 and Genentech. Clinical trial information: NCT01196390 .
Perioperative trastuzumab and pertuzumab in combination with FLOT versus FLOT alone for HER2-positive resectable esophagogastric adenocarcinoma: Final results of the PETRARCA multicenter randomized phase II trial of the AIO.
Authors: Hofheinz Ralf Dieter , Haag Georg Martin , Ettrich Thomas Jens , Borchert Kersten , Kretzschmar Albrecht , Teschendorf Christian , Siegler Gabriele Margareta , Ebert Matthias Philip , Goekkurt Eray , Welslau Manfred , Mahlberg Rolf , Homann Nils , Pink Daniel , Bechstein Wolf Otto , Reichardt Peter , Gaiser Timo , Sookthai Disorn , Pauligk Claudia , Goetze Thorsten Oliver , Al-Batran Salah-Eddin 
Published: May 2020

4502 Background: Perioperative FLOT is a standard of care for resectable, esophagogastric adenocarcinoma (EGA). This trial evaluates the addition of trastuzumab (tras) and pertuzumab (per) to FLOT for HER2-positive resectable patients (pts). Methods: PETRARCA is a prospective, multicenter, randomized, investigator initiated trial planned as a phase II/III investigation. We report the phase II part of this trial. Pts with HER2+ resectable EGA (≥ cT2 or cN+) were enrolled. Pts were randomized 1:1 to 4 pre- and post-operative cycles of FLOT (Docetaxel 50 mg/m²; Oxaliplatin 85 mg/m²; Leucovorin 200 mg/m²; 5-FU 2600 mg/m², q2w) (Arm A) or the same regimen with tras 8/6 mg/kg and per 840 mg q3w, followed by 9 cycles tras/per (arm B). Primary endpoint for the phase II part was the rate of pathological complete remission (pCR). Main secondary endpoints were DFS, OS and safety. Results: The trial closed prematurely and did not proceed to phase III. In total, 81 pts were randomized (A, 41; B, 40). Baseline characteristics were balanced (overall, male 79%; median age 60; cT3/T4 86%; cN+ 85%; GEJ 75%). 93% in arm A and 90% in arm B completed pre-OP treatment as planned. More pts had at least one dose modification in arm B (A, 44%; B, 70%). The pCR rate was significantly improved with tras/per (A, 12%; B, 35%; p = 0.02). Likewise, the rate of pathological lymph node negativity was higher with tras/per (A, 39%; B, 68%). R0-resection rate (A, 90%; B, 93%) and surgical morbidity (A: 43%; B, 44%) were comparable. Moreover, in-house mortality was equal in both arms (overall 2.5%). Median DFS was 26 months in arm A and not yet reached in arm B (HR 0.58, p = 0.14). After a median follow-up of 22 months median OS was not yet reached. DFS and OS rates [with 95% CI] at 24 months were 54% [38-71%] and 77% [63-90%] in arm A and 70% [55-85%] and 84% [72-96%] in arm B, respectively. In terms of toxicity more ≥ grade 3 adverse events were reported with tras/per (75% vs. 85%), especially diarrhea (5% vs. 41%) and leukopenia (13% vs 23%). Conclusions: The addition of tras/per to perioperative FLOT significantly improved pCR and nodal negativity rates in pts with Her2+ resectable esophagogastric adenocarcinoma at the price of higher rates of diarrhea and leukopenia. Clinical trial information: NCT02581462 .
Pembrolizumab versus paclitaxel for previously treated patients with PD-L1–positive advanced gastric or gastroesophageal junction cancer (GC): Update from the phase III KEYNOTE-061 trial.
Authors: Fuchs Charles S. , Özgüroğlu Mustafa , Bang Yung-Jue , Di Bartolomeo Maria , Mandalà Mario , Ryu Min-hee , Fornaro Lorenzo , Olesinski Tomasz , Caglevic Christian , Chung Hyun Cheol , Muro Kei , Van Cutsem Eric , Elme Anneli , Thuss-Patience Peter C. , Chau Ian , Ohtsu Atsushi , Bhagia Pooja , Wang Anran , Shih Chie-Schin , Shitara Kohei 
Published: May 2020

4503 Background: KEYNOTE-061 ( NCT02370498) is a global phase 3 study of pembrolizumab vs paclitaxel as second-line therapy for GC. At the time of primary analysis (data cutoff: Oct 26, 2017), in patients with PD-L1–positive status (combined positive score [CPS] ≥1), pembrolizumab did not significantly prolong overall survival (OS) vs paclitaxel (9.1 months vs 8.3 months) but did elicit a longer duration of response (DOR) and a favorable safety profile vs paclitaxel. We present results of KEYNOTE-061 in patients with CPS ≥1, ≥5, and ≥10 after 2 additional years of follow-up (cutoff: Oct 7, 2019). Methods: Adult patients with GC that progressed after platinum + fluoropyrimidine chemotherapy were randomly assigned 1:1 to pembrolizumab 200 mg Q3W for up to 35 cycles (~2 y) or standard-dose paclitaxel. OS and progression-free survival (PFS) in the CPS ≥1 population were the primary end points. Comparisons were made using stratified log-rank tests. Results: At the time of this analysis, 366/395 patients with CPS ≥1 had died (92.6%). Pembrolizumab prolonged OS vs paclitaxel in PD-L1–positive patients (Table). No significant differences appeared between groups in PFS (Table). Objective response rate (ORR) was higher for pembrolizumab in the CPS ≥10 group, and DOR was longer with pembrolizumab using all CPS cutoffs (Table). There were fewer drug-related adverse events (AEs) with pembrolizumab than paclitaxel in the overall population (53% vs 84%). Conclusions: This long-term analysis found that second-line pembrolizumab prolonged OS among patients with PD-L1–positive GC and led to fewer drug-related AEs vs paclitaxel. Clinical trial information: NCT02370498 . [Table: see text]
Efficacy, tolerability, and biologic activity of a novel regimen of tremelimumab (T) in combination with durvalumab (D) for patients (pts) with advanced hepatocellular carcinoma (aHCC).
Authors: Kelley Robin Kate , Sangro Bruno , Harris William Proctor , Ikeda Masafumi , Okusaka Takuji , Kang Yoon-Koo , Qin Shukui , Tai Wai Meng David , Lim Ho Yeong , Yau Thomas , Yong Wei-Peng , Cheng Ann-Lii , Gasbarrini Antonio , De Braud Filippo G. , Bruix Jordi , Borad Mitesh J. , He Philip , Negro Alejandra , Kudo Masatoshi , Abou-Alfa Ghassan K. 
Published: May 2020

4508 Background: The combination of dual immune checkpoint inhibitors (ICI) T (anti–CTLA-4) and D (anti–PD-L1) showed tolerability with a promising objective response rate (ORR) in the initial cohort of this study (NCT02519348). Subsequent evaluation of pts with solid tumors treated with increasing doses of T suggested priming with a higher dose of T may induce a stronger immune response and enhance anti-tumor activity. Thus, the randomized expansion cohorts comprised 4 arms evaluating T and D as monotherapies and 2 T+D regimens, including a novel T+D regimen featuring a single, priming dose of T. Methods: ICI-naïve pts with aHCC who progressed on, were intolerant to, or refused sorafenib were randomized to one of two T+D combinations: T300+D (T 300 mg + D 1500 mg 1 dose followed by D Q4 weekly [Q4W]) or T75+D (T 75 mg Q4W + D 1500 mg Q4W [4 doses] followed by D Q4W); or single agent D (1500 mg Q4W) or T (750 mg Q4W). Safety was the primary endpoint. ORR by blinded, independent central review using RECIST v1.1, duration of response (DoR), circulating lymphocytes, and overall survival (OS) were assessed. Results: At data cut-off (09/02/2019), 332 pts were enrolled. Median follow-ups were 11.7 months (mo) for T300+D, 14.6 (T75+D), 8.9 (D), and 15.8 (T). Treatment-related adverse event (trAE) incidences are shown (Table); no deaths were attributed to trAEs for T300+D or T. The T300+D arm had the highest confirmed ORR (DoR not reached [NR]) and longest OS (Table). A unique proliferative T cell profile was identified for pts in the T300+D arm, suggesting additive biologic activity for the combination, and showed pts with an OR exhibited high cytotoxic (CD8) counts. Conclusions: The encouraging clinical activity and tolerable safety profile suggest T300+D provides the best benefit-risk profile as opposed to T75+D or monotherapies. The unique pharmacodynamic activity of the T300+D regimen further supports its use in aHCC. T300+D and D are being evaluated in the ongoing phase III HIMALAYA study (NCT03298451) in first-line HCC vs sorafenib. Funding: AstraZeneca. Clinical trial information: NCT02519348 . [Table: see text]
Sintilimab in patients with advanced esophageal squamous cell carcinoma refractory to previous chemotherapy: A randomized, open-label phase II trial (ORIENT-2).
Authors: Xu Jianming , Li Yi , Fan Qingxia , Shu Yongqian , Wu Zhijun , Cui Tongjian , Gu Kangsheng , Tao Min , Wang Xiuwen , Cui Chengxu , Xu Nong , Xiao Juxiang , Gao Quanli , Liu Yunpeng , Zhang Tao , Zhou Hui , Wang Yan , Xu Linxinyu , Ma Zhuo , Wang Yanqi 
Published: May 2020

4511 Background: Patients (pts) with advanced esophageal squamous cell carcinoma (ESCC) refractory to first-line chemotherapy have limited treatment options. The study aims to evaluate the efficacy and safety of sintilimab, a PD-1 inhibitor, versus chemotherapy in these pts, and explore predictive value of PD-L1 and neutrophil-to-lymphocyte ratio (NLR) on efficacy of sintilimab. Methods: The open-label, multi-center phase 2 trial (NCT03116152) enrolled advanced ESCC pts refractory to first-line chemotherapy, and randomly assigned (1:1) them to receive sintilimab (200mg, Q3W) or chemotherapy (paclitaxel, 175mg/m2, Q3W; or irinotecan, 180mg/m2, Q2W), intravenously. The primary endpoint was overall survival (OS). Explorative endpoint were effects of PD-L1 and NLR on efficacy of sintilimab. Results: From May 16, 2017 to Aug 30, 2018, 190 pts were randomly assigned to sintilimab or chemotherapy (n = 95 per group). With the median follow-up of 7.2 months for sintilimab group and 6.2 months for chemotherapy group, the median OS in sintilimab was significantly higher than chemotherapy (7.2m vs. 6.2m, hazard ratio [HR] 0.70, P = 0.034). The objective response rate (ORR) was greater in sintilimab than chemotherapy with 12.6% vs. 6.3%, and the median duration of response was longer (8.3m vs. 6.2m). Incidences of treatment-related adverse events (TRAEs) of any grade (54.3% vs. 90.8%) and of grade 3-5 (20.2% vs. 39.1%) were both numerically less in sintilimab than in chemotherapy. The ORR in sintilimab versus chemotherapy in pts with tumor PD-L1 tumor proportion score (TPS) ≥1% and with TPS ≥10% were 20.2% vs. 0%, and 35.7% vs. 0%, respectively. In sintilimab group, pts with low NLR ( < 3) had a significant longer median OS (HR 0.54, P = 0.019) than with high NLR. Conclusions: Sintilimab was superior to chemotherapy with a significantly prolonged survival benefit and a favorable safety profile in pts with advanced ESCC refractory to first-line chemotherapy. High tumor PD-L1 expression (TPS ≥1% or ≥10%) might indicate more response benefit to sintilimab for these pts, and low NLR might be a positive predictive factor for sintilimab. Clinical trial information: NCT03116152 .
Phase II study assessing tolerability, efficacy, and biomarkers for durvalumab (D) ± tremelimumab (T) and gemcitabine/cisplatin (GemCis) in chemo-naïve advanced biliary tract cancer (aBTC).
Authors: Oh Do-Youn , Lee Kyung-Hun , Lee Dae-Won , Kim Tae Yong , Bang Ju-Hee , Nam Ah-Rong , Lee Young , Zhang Qu , Rebelatto Marlon , Li Weimin , Kim Jin Won 
Published: May 2020

4520 Background: In aBTC, GemCis is the standard of care as 1st-line treatment. Immunotherapies have shown early promising efficacy in some BTC patients (pts). We assessed D (anti-PD-L1) ± T (anti-CTLA-4) and GemCis in 1L BTC pts, including an extensive biomarker analysis (NCT03046862). Methods: Pts were first enrolled in the biomarker cohort (BMC) to receive 1 cycle of Gem 1000 mg/m2 + Cis 25 mg/m2 on D1 & D8, followed by GemCis + D 1120 mg and T 75 mg, Q3W until disease progression (PD). Subsequent pts were allocated to GemCis + D (3 combo cohort [3C]) or GemCis + D+T (4 combo cohort [4C]) until PD. In all cohorts, tumor biopsies were obtained pre-treatment, after 1 cycle, and at PD. Blood samples for ctDNA were obtained every cycle. Results: 121 pts were enrolled. Median follow-up durations were 28.5 months (m; 95% CI, 26.5-30.5), 11.3 m (95% CI, 9.1-13.5), and 11.9m (95% CI, 8.4-15.4) in the BMC, 3C, and 4C arms, respectively. Efficacy data are shown (Table). The most common adverse events (AEs, any grade) were neutropenia (54.5%), nausea (59.5%), and pruritus (55.44%). The most common grade 3/4 AEs were neutropenia (50.4%), anemia (35.5%), and thrombocytopenia (16.5%). In the BMC cohort, frequent mutations were found in DNA damage repair, cell cycle regulation, and genome instability genes (eg, ATM, BRCA2, POLE, MSH2, CDKN2A). Distinct somatic variants were detected in responders vs non-responders. Baseline tissue TMB did not correlate with PFS or OS. Reductions in ctDNA variant allele frequency (VAF) were more prominent among responders during early D+T cycles. ctDNA VAF on C3, D1 was significantly correlated with ORR ( P< 0.015). Pretreatment PD-L1 expression was not associated with efficacy, but PD-L1 expression after 1st GemCis cycle trended with improved PFS. Conclusions: These are the first clinical data of D±T plus chemotherapy in chemo-naïve aBTC pts. The addition of immunotherapy to chemotherapy was tolerable and showed very promising efficacy. Biomarker analyses show early signs of markers associated with response. The combination of GemCis + D is being investigated in the Phase 3 TOPAZ-1 trial (NCT03875235). Clinical trial information: NCT03046862 . [Table: see text]
Disease-free survival as a surrogate for overall survival in neoadjuvant trials of gastroesophageal adenocarcinoma: Pooled analysis of individual patient data from randomized controlled trials.
Authors: Ronellenfitsch Ulrich , Jensen Katrin , Seide Svenja , Kieser Meinhard , Schwarzbach Matthias , Slanger Tracy E , Burmeister Bryan , Kelsen David Paul , Niedzwiecki Donna , Piessen Guillaume , Schumacher Christoph , Urba Susan , Van De Velde Cornelis J. H. , Ychou Marc , Hofheinz Ralf Dieter , Lorenzen Sylvie 
Published: May 2020

4533 Background: Disease-free survival (DFS) is an appealing surrogate endpoint for overall survival (OS) in trials on neoadjuvant or adjuvant cancer therapy, because it is available faster and with less follow-up effort. The aim of this study was to assess if DFS can be a valid surrogate endpoint for OS when comparing neoadjuvant treatment followed by surgery to surgery alone for gastroesophageal adenocarcinoma. Methods: Individual patient data (IPD) from eight randomized controlled trials (n = 1,126 patients) which compared neoadjuvant therapy followed by surgery with surgery alone for gastroesophageal adenocarcinoma were used for the analysis. Correlation between OS-time and DFS-time was calculated. Kaplan-Meier survival curves and corresponding hazard ratios (HRs) for treatment effects were separately determined for each trial. Subsequently, HRs were pooled in a meta-analysis using a random-effects model. An error-in-variables linear regression model was used to compare observed and predicted values. The minimum treatment effect on DFS necessary to predict a non-zero treatment effect on OS was estimated by calculating the surrogate threshold effect. Results: OS-time correlated strongly with DFS-time. HRs for OS and DFS were highly similar for all single trials. The meta-analysis yielded almost identical overall HRs for treatment effects on OS and DFS. The determination coefficient for the association between HRs for OS and DFS was 0.912 (95% confidence interval 0.75-1.0), indicating a strong trial-level surrogacy between OS and DFS. The surrogate threshold effect was calculated at 0.79, indicating that a future trial yielding a hazard ratio for the treatment effect on DFS < 0.79 could be expected with a 95% probability to yield a hazard ratio for the treatment effect on OS < 1. Conclusions: DFS and OS strongly correlate both after neoadjuvant therapy followed by surgery and after surgery alone for gastroesophageal adenocarcinoma. Likewise, the treatment effects on the two endpoints are very similar. Consequently, DFS can be regarded an appropriate surrogate endpoint for OS in trials on neoadjuvant therapy for gastroesophageal adenocarcinoma.
Camrelizumab combined with FOLFOX as neoadjuvant therapy for resectable locally advanced gastric and gastroesophageal junction adenocarcinoma.
Authors: Liu Ying , Han Guangsen , Li Hongle , Zhao Yuzhou , Zhuang Jing , Wang Gangcheng , Li Baodong , Wang Jinbang , Li Zhimeng , Xia Qingxin , Ma Jie , Zhang Chengjuan , Yu Juan , Li Ke , Xu Shuning , Qiao Lei , Kuang Gaizhen , Li Danyang 
Published: May 2020

4536 Background: Neoadjuvant chemotherapy has been demonstrated to improve the pathological complete response(pCR) and 5-year survival rate of patients with locally advanced gastric and gastroesophageal junction adenocarcinoma (GC/GEJC). Immunotherapy has become a new promising treatment for advanced GC/GEJC. Therefore, we intended to evaluate the safety and efficacy of Camrelizumab (anti-PD-1 antibody) combined with FOLFOX as the neoadjuvant therapy for patients with locally advanced GC/GEJC. Methods: Eligiblepatients were locally advanced GC/GEJC with clinical stage≥T2 and/or positive lymphoglandula confirmed by endoscopic ultrasonography (EUS) and imaging. They received 4 cycles neoadjuvant therapy which including Camrelizumab(200mg ivgtt D1), FOLFOX(Oxaliplatin 85mg/m2 ivgtt D1, 5-Fu 400mg/m2 iv D1, LV 200mg/m2 ivgtt D1, 5-Fu 2.4mg/m2 CIV 46 hours) every 14 days. Imaging evaluation was performed in 2-4 weeks after neoadjuvant therapy. Patients without progression disease (PD) received D2 radical gastrectomy. The primary endpoint was pCR, the secondary endpoints were R0 resection rate and safety. Results: From July 24 2019 to January 31 2020, 16 patients were eligible. The median age was 57 years (29-72 years). A total of 11(69%) males and 5(31%) females, ECOG PS 0 (n=9, 56%), ECOG PS 1 (n=7, 44%). All the patients completed 4 cycles treatment and none of them was confirmed PD by image. One of the patients refused gastrectomy and withdraw from the study. The other 15 patients underwent operation. Unfortunately, intraperitoneal metastases were confirmed in 2 patients during operation. 13 patients received D2 radical gastrectomy and all of them experienced R0 resection. Among the 13 evaluable patients, 1 patient (8%) was observed pCR, 3 patients (23%) experienced TRG1, 10 patients (77%) achieved stage reduction. Notably, 8 patients (62%) had lymphonodus pCR. The grade 3-4 treatment-related AEs were neutropenia (n=3, 19%), leukopenia (n=2, 13%) and anorexia (n=1, 6%). No serious AEs resulted in termination of treatment. Either severe immune-related AEs or treatment-related death was not observed. Conclusions: Camrelizumab combined with FOLFOX as neoadjuvant regimen in patients with locally advanced GC/GEJC showed promising pCR with good tolerance. Clinical trial information: NCT03939962 . [Table: see text]