Resectable Gastric/Gastroesophageal Junction AdenocarcinomaPhase 2/3NCT07643623
Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
A Phase 2/3 study testing tegafur, Gimeracil and Oteracil Potassium Capsules, Sintilimab and Ipilimumab N01 in people with Resectable Gastric/Gastroesophageal Junction Adenocarcinoma, run by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. at 1 site in China.
Trial summary
This is a Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined with Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- tegafur, Gimeracil and Oteracil Potassium Capsules, Sintilimab and Ipilimumab N01
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 720 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2026to 31 Dec 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Signed written Informed Consent Form (ICF) and ability to comply with protocol-specified visits and related procedures.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival ≥ 6 months.
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ). For GEJ cancer, only Siewert type III and Siewert type II participants not requiring combined thoracotomy are eligible.
- Clinical stage T3-4Nany or TanyN+M0 (stage II-IVa) gastric/GEJ adenocarcinoma confirmed by endoscopic ultrasound or contrast-enhanced CT/MRI within 4 weeks before the first dose, per the American Joint Committee on Cancer (AJCC) 8th edition gastric cancer TNM staging system.
- Within 4 weeks before the first dose, evaluated by a responsible surgeon based on medical history and confirmed to meet study requirements for radical R0 resection.
Who cannot join
- Histologically or cytologically confirmed other pathologic types (e.g., squamous cell carcinoma, sarcoma, undifferentiated carcinoma) or combined gastrointestinal stromal tumor (GIST) before randomization.
- Suspicious metastatic lesions or locally advanced unresectable disease, regardless of stage.
- History of gastrointestinal perforation or fistula within 6 months before randomization. May be enrolled if perforation/fistula has been surgically treated (repaired/resected) and disease recovery/remission is confirmed by the investigator.
- Active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
- Inability to swallow, malabsorption syndrome, or uncontrolled nausea/vomiting/diarrhea, or other severe gastrointestinal diseases affecting drug intake/absorption.
- Any life-threatening bleeding event within 3 months before randomization, or grade 3/4 gastrointestinal/variceal bleeding requiring endoscopic/surgical intervention.
- Active uncontrolled bleeding or known bleeding diathesis.
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua Xu, 020-87343468, xurh@sysucc.org.cn
About this study
Official title: A Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
This is a Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined with Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma.
- Being tested
- tegafur, Gimeracil and Oteracil Potassium Capsules, Sintilimab Placebo, Sintilimab, Ipilimumab N01, Oxaliplatin for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tegafur, Gimeracil and Oteracil Potassium CapsulesDrug
40mg/m2, D1-14 BID PO Q3W
Sintilimab PlaceboDrug
200 mg, D1 IV Q3W
SintilimabDrug
200mg D1 IV Q3W
Ipilimumab N01Drug
1mg/kg, D1 IV Q6W
Oxaliplatin for injectionDrug
130 mg/m2 D1 IV Q3W
Ipilimumab N01 PlaceboDrug
1mg/kg, D1 IV Q6W
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab | Active comparator | Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery.
adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. Receives: Drug: tegafur, Gimeracil and Oteracil Potassium Capsules; Drug: Sintilimab; Drug: Oxaliplatin for injection; Drug: Ipilimumab N01 Placebo |
| Sintilimab+Ipilimumab N01 | Experimental | Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery.
adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. Receives: Drug: tegafur, Gimeracil and Oteracil Potassium Capsules; Drug: Sintilimab; Drug: Ipilimumab N01; Drug: Oxaliplatin for injection |
| Sintilimab placebo+Ipilimumab N01 placebo | Active comparator | Neoadjuvant Treatment period: up to 3 cycles of sintilimab placebo plus chemotherapy in combination with Ipilimumab N01 Placebo prior to surgery.
adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab placebo plus chemotherapy, and then receive sintilimab placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. Receives: Drug: tegafur, Gimeracil and Oteracil Potassium Capsules; Drug: Sintilimab Placebo; Drug: Oxaliplatin for injection; Drug: Ipilimumab N01 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
The MPR rate is defined as the proportion of participants with a Tumor Regression Grade (TRG) score of 0 or 1 in the primary tumor after radical surgical resection following neoadjuvant therapy.
Measured: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Event-Free Survival (EFS)
The EFS is defined as the time from randomization to the first occurrence of disease progression precluding curative resection, postoperative local recurrence, distant metastasis, or death from any cause.
Measured: Up to approximately 5 years
Secondary outcomes (6)
pathological Complete Response (pCR) rate
The pCR rate is defined as the proportion of participants with no residual viable tumor in both the primary tumor and lymph nodes after radical surgical resection following neoadjuvant therapy.
Measured: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Clinical Down-staging Rate
Clinical downstaging rate refers to the proportion of participants with a reduction in clinical TNM (cTNM) stage after neoadjuvant therapy.
Measured: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
R0 resection rate
The R0 resection rate is defined as the proportion of participants who underwent R0 resection.
Measured: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 5 years
numbers of subjects with adverse events
defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Measured: Up to approximately 5 years
numbers of subjects with serious adverse events
Defined as any serious untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start31 Jul 2026
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Gastric/Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643623
- Sponsor's protocol ID
- CIBI310M301
- Status last verified
- Aug 2026
- First submitted
- 4 Jun 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07643623
- Acronym / sponsor ID
- CIBI310M301
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined with Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sintilimab | Active comparator | Drug: tegafur, Gimeracil and Oteracil Potassium Capsules, Drug: Sintilimab, Drug: Oxaliplatin for injection, Drug: Ipilimumab N01 PlaceboNeoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
| Sintilimab+Ipilimumab N01 | Experimental | Drug: tegafur, Gimeracil and Oteracil Potassium Capsules, Drug: Sintilimab, Drug: Ipilimumab N01, Drug: Oxaliplatin for injectionNeoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
| Sintilimab placebo+Ipilimumab N01 placebo | Active comparator | Drug: tegafur, Gimeracil and Oteracil Potassium Capsules, Drug: Sintilimab Placebo, Drug: Oxaliplatin for injection, Drug: Ipilimumab N01 PlaceboNeoadjuvant Treatment period: up to 3 cycles of sintilimab placebo plus chemotherapy in combination with Ipilimumab N01 Placebo prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab placebo plus chemotherapy, and then receive sintilimab placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed written Informed Consent Form (ICF) and ability to comply with protocol-specified visits and related procedures.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival ≥ 6 months.
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ). For GEJ cancer, only Siewert type III and Siewert type II participants not requiring combined thoracotomy are eligible.
Key exclusion criteria (7 listed)
- Histologically or cytologically confirmed other pathologic types (e.g., squamous cell carcinoma, sarcoma, undifferentiated carcinoma) or combined gastrointestinal stromal tumor (GIST) before randomization.
- Suspicious metastatic lesions or locally advanced unresectable disease, regardless of stage.
- History of gastrointestinal perforation or fistula within 6 months before randomization. May be enrolled if perforation/fistula has been surgically treated (repaired/resected) and disease recovery/remission is confirmed by the investigator.
- Active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
- Inability to swallow, malabsorption syndrome, or uncontrolled nausea/vomiting/diarrhea, or other severe gastrointestinal diseases affecting drug intake/absorption.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tegafur, Gimeracil and Oteracil Potassium Capsules40mg/m2, D1-14 BID PO Q3W | Drug | Sintilimab, Sintilimab placebo+Ipilimumab N01 placebo, Sintilimab+Ipilimumab N01 |
| Sintilimab Placebo200 mg, D1 IV Q3W | Drug | Sintilimab placebo+Ipilimumab N01 placebo |
| Sintilimab200mg D1 IV Q3W | Drug | Sintilimab, Sintilimab+Ipilimumab N01 |
| Ipilimumab N011mg/kg, D1 IV Q6W | Drug | Sintilimab+Ipilimumab N01 |
| Oxaliplatin for injection130 mg/m2 D1 IV Q3W | Drug | Sintilimab, Sintilimab placebo+Ipilimumab N01 placebo, Sintilimab+Ipilimumab N01 |
| Ipilimumab N01 Placebo1mg/kg, D1 IV Q6W | Drug | Sintilimab, Sintilimab placebo+Ipilimumab N01 placebo |
Primary outcome
Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
The MPR rate is defined as the proportion of participants with a Tumor Regression Grade (TRG) score of 0 or 1 in the primary tumor after radical surgical resection following neoadjuvant therapy.
Event-Free Survival (EFS)
Time frame: Up to approximately 5 years
The EFS is defined as the time from randomization to the first occurrence of disease progression precluding curative resection, postoperative local recurrence, distant metastasis, or death from any cause.
6 secondary outcomes
pathological Complete Response (pCR) rate
Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Clinical Down-staging Rate
Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
R0 resection rate
Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Overall survival (OS)
Time frame: Up to approximately 5 years
numbers of subjects with adverse events
Time frame: Up to approximately 5 years
numbers of subjects with serious adverse events
Time frame: Up to approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing tegafur, Gimeracil and Oteracil Potassium Capsules, Sintilimab and Ipilimumab N01 in people with Resectable Gastric/Gastroesophageal Junction Adenocarcinoma, run by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunxian Hu (+86 021 3183 7200, chunxian.hu@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma (time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.