Clinical trial NCT03472365: A Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer
Official title: A Randomized Phase 2 Study to Evaluate Safety and Efficacy of the Combination of SHR-1210 With Capecitabine + Oxaliplatin or Apatinib as First-line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
GastroEsophageal Cancer
Keywords: PD-1
SHR-1210
Capecitabine
Oxaliplatin
Apatinib
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-21
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to estimate overall response rate (ORR) of SHR-1210 combined with capecitabine and oxaliplatin or with apatinib as first-line treatment in subjects with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Detailed description: Approximately 110 participants will be assigned to SHR-1210 + capecitabine + oxaliplatin combination therapy (Cohort 1), or SHR-1210 + apatinib combination therapy (Cohort 2).

Eligibility criteria: Inclusion Criteria:

* Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ).
* Age ≥ 18 years old, male or female.
* NO previous therapy for advanced/metastatic disease of GC/GEJ (including HER2 inhibitor). Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled.
* Has measurable disease per RECIST 1.1.
* Life expectancy ≥ 12 weeks.
* Eastern Cooperative Group (ECOG) performance status of 0 to 1.
* Has adequate organ function.
* Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs.

Exclusion Criteria:

* Has known HER2-positive status.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or a VEGFR inhibitor.
* Has known active central nervous system metastases.
* Has received a live vaccine within 4 weeks prior to the first dose of study treatment.
* With any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
* Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention.
* Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg.
* Coagulation abnormalities (INR \> 1.5 or APTT \> 1.5×ULN), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.

Primary outcomes:
measure: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
timeFrame: Up to approximately 6 months.
Secondary outcomes:
measure: Progression-free Survival (PFS) Per RECIST 1.1
timeFrame: Up to 24 months.
measure: Duration of Response (DOR) Per RECIST 1.1
timeFrame: Up to 24 months.
measure: Disease Control Rate (DCR) Per RECIST 1.1
timeFrame: Up to 24 months.
measure: Number of Subjects With Treatment-related Adverse Events (AEs)
timeFrame: Up to 24 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Lin Shen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peng Z, Wei J, Wang F, Ying J, Deng Y, Gu K, Cheng Y, Yuan X, Xiao J, Tai Y, Wang L, Zou J, Zhang Y, Shen L. Camrelizumab Combined with Chemotherapy Followed by Camrelizumab plus Apatinib as First-line Therapy for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. Clin Cancer Res. 2021 Jun 1;27(11):3069-3078. doi: 10.1158/1078-0432.CCR-20-4691. Epub 2021 Mar 25.