A Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-02

Study Completion Date

2020-11-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Study To Evaluate Camrelizumab (SHR-1210) Plus Capecitabine and Oxaliplatin Followed by Sequential Treatment With Camrelizumab Plus Apatinib Mesylate in Advanced or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJ) Without Prior Systemic Therapy

NCT03813784

Gastric Cancer GastroEsophageal Cancer

COMPLETED PHASE3

Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the Treatment of Advanced Gastric and Esophageal Cancer

NCT06247956

Advanced Gastric Adenocarcinoma and Esophageal Squamous Cell Carcinoma

ACTIVE_NOT_RECRUITING PHASE2

Efficacy and Safety of Apatinib Combined With S-1 for Patients With Advance Gastric Cancer

NCT04338438

Gastric Cancer

COMPLETED PHASE2

Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC

NCT04342910

Gastric Cancer

RECRUITING PHASE3

PD-1 Antibody(SHR-1210) Plus Apatinib Combined With POF in Advanced Gastric Cancer

NCT04174339

Advanced Gastric Adenocarcinoma

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer GastroEsophageal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus capecitabine 1000 mg/m\^2 twice daily (BID) by continuous oral administration for 14 days, followed by a recovery period of 7 days, plus oxaliplatin 130 mg/m\^2, IV q3w; for 4-6 cycles followed by SHR-1210 plus apatinib 375 mg PO qd if there is no PD.

Group Type EXPERIMENTAL

SHR-1210

Intervention Type BIOLOGICAL

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

Capecitabine

Intervention Type DRUG

1000 mg/m\^2 administered as continuous oral twice daily (BID) of each 3-week cycle.

Oxaliplatin

Intervention Type DRUG

130 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle.

Apatinib

Intervention Type DRUG

375 mg administered as continuous oral once daily (QD) of each 3-week cycle.

Cohort 2

Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus apatinib 375 mg daily (QD) continuous oral administration of each 3-week cycle.

Group Type EXPERIMENTAL

SHR-1210

Intervention Type BIOLOGICAL

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

Apatinib

Intervention Type DRUG

375 mg administered as continuous oral once daily (QD) of each 3-week cycle.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SHR-1210

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

Intervention Type BIOLOGICAL

Capecitabine

1000 mg/m\^2 administered as continuous oral twice daily (BID) of each 3-week cycle.

Intervention Type DRUG

Oxaliplatin

130 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle.

Intervention Type DRUG

Apatinib

375 mg administered as continuous oral once daily (QD) of each 3-week cycle.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Camrelizumab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No