Clinical trial NCT04208347: Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer
Official title: Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Resectable Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: A Multicenter, Randomized Phase II-III Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy, safety and tolerability of chemotherapy and apatinib with or without camrelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

* Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0;
* Plans to proceed to surgery following pre-operative chemotherapy.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
* Has adequate organ function.
* Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
* Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
* Has life expectancy of greater than 12 months.

Exclusion Criteria:

* Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
* Known hypersensitivity to any of the study drugs or excipients.
* Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
* Congenital or acquired immune deficiency (e.g. HIV infected)

Primary outcomes:
measure: Pathological Complete Response (pCR)
timeFrame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
measure: Event-free Survival (EFS)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Major pathological response(MPR)
timeFrame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
measure: Margin-free (R0) resection rate
timeFrame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
measure: DFS
timeFrame: up to 2 years
measure: OS
timeFrame: up to 3 years
measure: Downstaging of N stage
timeFrame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
measure: AEs
timeFrame: Up to approximately 18 months
Other outcomes:
Locations:
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Changzhi
country: China
facility: Heping Hospital Affiliated to Changzhi Medical College
city: Chengdu
country: China
facility: Sichuan Cancer Hospital & Institute
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
city: Haikou
country: China
facility: Hainan Cancer Hospital
city: Hangzhou
country: China
facility: Cancer Hospital of the University of Chinese Academy of Sciences
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
city: Hefei
country: China
facility: Hefei Cancer Hospital, Chinese Academy of Sciences
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
city: Shenyang
country: China
facility: Liaoning Cancer Hospita & Institute
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
city: Siping
country: China
facility: Jilin Guowen Hospital
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
city: Xian
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
city: Xian
country: China
facility: Tangdu Hospital
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Zhengzhou
country: China
facility: Henan Provincial Cancer Hospital
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
Study officials:
affiliation: Ruijin Hospital
name: Zhenggang Zhu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zheng Y, Wang Z, Yan C, Yan M, Hou Z, Zheng R, Zhu Z, Li C. Protocol for a randomized controlled trial of perioperative S-1 plus oxaliplatin combined with apatinib and camrelizumab in patients with resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma. Ann Transl Med. 2020 Dec;8(24):1684. doi: 10.21037/atm-20-7802.
citation: Zheng Y, Yang X, Yan C, Feng R, Sah BK, Yang Z, Zhu Z, Liu W, Xu W, Ni Z, Beeharry MK, Hua Z, Yan M, Zhu Z, Li C. Effect of apatinib plus neoadjuvant chemotherapy followed by resection on pathologic response in patients with locally advanced gastric adenocarcinoma: A single-arm, open-label, phase II trial. Eur J Cancer. 2020 May;130:12-19. doi: 10.1016/j.ejca.2020.02.013. Epub 2020 Mar 11.