Gastric CancerPhase 3NCT04342910
Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC
A Phase 3 study testing camrelizumab, Apatinib Mesylate and Paclitaxel in people with Gastric Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- camrelizumab, Apatinib Mesylate and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2020to 1 Sep 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
- Confirmed metastatic or locally advanced, unresectable disease.
- Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine or platinum/taxane doublet.
- Willing to provide tumor tissue for PD-L1 biomarker analysis.
- Human epidermal growth factor receptor 2 (HER-2/neu) status known and participants with HER2/neu positive tumors show documentation of previous treatment containing trastuzumab.
- ECOG performance status of 0 to 1.
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- Life expectancy of more than 12 weeks.
- Signing the informed consent forms.
- Adequate bone marrow, liver and renal function.
Who cannot join
- Squamous cell or undifferentiated gastric cancer.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed.
- Clinically significant cardiovascular and cerebrovascular diseases.
- Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
- Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
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- Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization.
- Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.
- Prior systemic chemotherapy, radiotherapy and surgery within 4 weeks before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital, Academy of Military Medical Sciences
Beijing
Jianming Xu, PhD
About this study
Official title: A Study of Camrelizumab (SHR-1210) Combined With Apatinib Versus Paclitaxel or Irinotecan in Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma Progressed After First-line Chemotherapy
This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.
- Conditions
- Gastric Cancer
- Being tested
- camrelizumab, Apatinib Mesylate, Paclitaxel, Irinotecan
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
camrelizumabDrug
Also called SHR-1210
200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.
Apatinib MesylateDrug
250 mg qd
PaclitaxelDrug
80 mg/m^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
IrinotecanDrug
180 mg/m^2 administered as IV infusion on Days 1, and 15 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| camrelizumab (SHR-1210) combined with apatinib | Experimental | Participants will receive camrelizumab on Day 1 and Day 15 of each 28-day cycle and apatinib mg/day up to 2 years. Receives: Drug: camrelizumab; Drug: Apatinib Mesylate |
| Paclitaxel or Irinotecan | Active comparator | Participants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle, or irinotecan on Days 1 and 15 of each 28-day cycle. Receives: Drug: Paclitaxel; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) in PD-L1 Positive Participants.
OS was defined as the time from randomization to death due to any cause.
Measured: Up to 27 months
Secondary outcomes (13)
Overall Survival (OS) in All Participants.
OS was defined as the time from randomization to death due to any cause.
Measured: Up to 27 months
Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment in All Participants or in PD-L1 Positive Participants.
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first.
Measured: Up to 27 months
Time to Tumor Progression (TTP) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment in All Participants.
Measured: Up to 27 months
Time to Failure (TTF) in All Participants or in PD-L1 Positive Participants
TTF was defined as the time from randomization to treatment discontinuation caused by any reason.
Measured: Up to 27 months
Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment.
Measured: Up to 27 months
Duration of Response (DOR) According to RECIST 1.1 Based on investigator assessment in All Participants or in PD-L1 Positive Participants.
DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Measured: Up to 27 months
Disease Control Rate (DCR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
DCR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR or SD according to RECIST 1.1 based on investigator assessment.
Measured: Up to 27 months
Time to Response (TTR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
TTR was defined as the time from randomization to the first documented evidence of CR or PR.
Measured: Up to 27 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03.
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03.
Measured: Up to 27 months
Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.
Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.
Measured: Up to 27 months
Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
Measured: Up to 27 months
Serum concentration of camrelizumab
Serum concentration of camrelizumab
Measured: Up to 27 months
Plasma concentration of apatinib
plasma concentration of apatinib
Measured: Up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start21 Sep 2020
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianming Xu, Ph.D, Principal investigator, Affiliated Hospital, Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342910
- Sponsor's protocol ID
- SHR-1210-III-316
- Status last verified
- Jan 2026
- First submitted
- 9 Apr 2020
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No