Immunotherapy-Chemo cocktail aims to tame stomach cancer
NCT ID NCT03813784
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This Phase 3 trial tested whether adding the immunotherapy drug camrelizumab to standard chemotherapy, followed by camrelizumab plus the targeted drug apatinib, helps people with advanced stomach or gastroesophageal junction cancer live longer. The study enrolled 885 participants who had not received prior treatment for advanced disease. The goal is to see if this combination improves overall survival compared to chemotherapy alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- camrelizumab (an immunotherapy drug) combined with capecitabine and oxaliplatin (chemotherapy), followed by camrelizumab plus apatinib (a targeted therapy)
- What this could lead to
- If successful, this combination could offer a new first-line treatment option that helps people with advanced gastric or GEJ cancer live longer and control their disease better.
- What could go wrong
- This is a Phase 3 trial, but results are not yet published. The combination may cause significant side effects, and not all patients may benefit, especially those with low PD-L1 levels.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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885 people
The number who actually took part.
- Started
-
Mar 2019
- Finished
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Jun 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or mestastatic 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 HER-2 inhibitor). Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled. * Has measurable disease per RECIST 1.1 * 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 known active central nervous system metastatases * Has received a live vaccine within 4 weeks prior to the first dose of study treatment * With any acitve autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatititis, 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. * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or a VEGFR inhibitor. * 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), orventricular arrhythmia which need medical intervention. * Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents: systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Cancer Hospital, Peking University
Beijing, Beijing Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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