Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma

NCT07643623 | Not Yet Recruiting Phase 2

• 1 other identifier: CIBI310M301
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Resectable Gastric/Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to approximately 5 years

Secondary Outcomes (6)

• pathological Complete Response (pCR) rate

  Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )

• Clinical Down-staging Rate

  Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )

• R0 resection rate

  Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )

• Overall survival (OS)

  Up to approximately 5 years

• numbers of subjects with adverse events

  Up to approximately 5 years

Study Arms (3)

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.

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.

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.

Drug: tegafur, Gimeracil and Oteracil Potassium Capsules; Drug: Sintilimab Placebo; Drug: Oxaliplatin for injection; Drug: Ipilimumab N01 Placebo

Interventions

Sintilimab Placebo DRUG

200 mg, D1 IV Q3W

Sintilimab placebo+Ipilimumab N01 placebo

Sintilimab DRUG

200mg D1 IV Q3W

Sintilimab; Sintilimab+Ipilimumab N01

Ipilimumab N01 DRUG

1mg/kg, D1 IV Q6W

Sintilimab+Ipilimumab N01

Oxaliplatin for injection DRUG

130 mg/m2 D1 IV Q3W

Sintilimab; Sintilimab placebo+Ipilimumab N01 placebo; Sintilimab+Ipilimumab N01

Ipilimumab N01 Placebo DRUG

1mg/kg, D1 IV Q6W

Sintilimab; Sintilimab placebo+Ipilimumab N01 placebo

tegafur, Gimeracil and Oteracil Potassium Capsules DRUG

40mg/m2, D1-14 BID PO Q3W

Sintilimab; Sintilimab placebo+Ipilimumab N01 placebo; Sintilimab+Ipilimumab N01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Interventions

Tegafur; gimeracil; potassium oxonate; sintilimab; Oxaliplatin; Injections

Intervention Hierarchy (Ancestors)

Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Chunxian Hu

CONTACT

+86 021 3183 7200; chunxian.hu@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 11, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

CN (1)