Ipilimumab (N01) Plus Sintilimab and Modified XELOX as Conversion Therapy in Unresectable Locally Advanced Gastric Cancer

NCT07638631 | Not Yet Recruiting Phase 2

• 1 other identifier: DIAMC-GC
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was a prospective, single-arm, multi-center, phase Ⅱ clinical study to investigate the efficacy and safety of ipilimumab injection N01 combined with sintilimab and modified XELOX conversion therapy in patients with unresectable locally advanced gastric cancer who had not received systemic treatment.

Conditions

Locally Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Surgical conversion rate

  Ratio of subjects who underwent surgical resection to all subjects who received a conversion therapy regimen

  12 months

Secondary Outcomes (4)

• pCR rate

  12 months

• MPR rate

  12 months

• ORR

  12 months

• AEs

  Baseline up to 3 years

Study Arms (1)

Single Arm

EXPERIMENTAL

Ipilimumab injection N01, every 6 weeks for cycles (up to 4 cycles), sintilimab every 21 days for cycles, modified (60% standard dose) XELOX (oxaliplatin 78mg/m2, d1; Capecitabine 600mg/m2, bid, d1-14, q3w). Tumor assessments were performed every 8 weeks, and radical surgery was performed within 2 to 4 weeks after the last dose of study drug if the investigator's assessment was feasible; If the evaluation showed that radical surgery could not be performed, the conversion therapy was continued until the evaluation was operable. Non-pd patients who were still inoperable continued to receive sintilimab combined with XELOX treatment, and PD patients were excluded from the group. Combination therapy was administered until disease progression or intolerable toxicity. Postoperative adjuvant treatment with sintilimab combined with XELOX (the total number of chemotherapy cycles in perioperative treatment should not exceed 8 cycles, and the total number of sintilimab treatment should be 1 year)

Drug: Ipilimumab injection N01; Drug: Sintilimab; Drug: Modified (60% standard dose) XELOX

Interventions

Ipilimumab injection N01 DRUG

Ipilimumab injection N01 (R\&D Code: IBI310) is a recombinant fully human anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody independently developed by Xinda Biotechnology (Suzhou) Co., Ltd. It can specifically bind to CTLA-4 molecule, thereby blocking CTLA-4-mediated T cell suppression, promoting T cell activation and proliferation, and enhancing tumor immune response. To achieve anti-tumor effect.

Single Arm

Sintilimab DRUG

Sintilimab is a recombinant fully human IgG4 PD-1 monoclonal antibody, which is a Class 1 new drug independently developed by Xinda Biotechnology (Suzhou) Co., Ltd. Sintilimab can specifically bind to PD-1 molecules on the surface of T lymphocytes, thereby blocking the PD-1/PD-L1 pathway leading to tumor immune tolerance. To reactivate the anti-tumor activity of T lymphocytes and achieve the purpose of tumor treatment.

Single Arm

Modified (60% standard dose) XELOX DRUG

Modified (60% standard dose) XELOX: (Oxaliplatin 78mg/m2,d1; capecitabine 600mg/m2,bid,d1-14,q3w)

Single Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provided written informed consent before performing any trial-related procedures;
• Age ≥18 years old and ≤80 years old, regardless of gender;
• Histologically confirmed gastric or gastroesophageal junction adenocarcinoma, PDL1 CPS≥1, and unresectable locally advanced gastric cancer confirmed by MDT or investigator assessment (based on imaging and EUS assessment). Conclusions: The main reasons for unresectable locally advanced gastric cancer at initial diagnosis include: severe invasion of the primary tumor, inability to separate from surrounding organs or wrap around important blood vessels, or metastasis and fixation of regional lymph nodes, and inability to achieve R0 resection according to MDT discussion or investigator evaluation. R0 resection was considered unresectable if a Whipple's operation was performed in conjunction with it.
• At least one radiographic measurable lesion according to response evaluation Criteria in Solid Tumors (RECIST, version 1.1);
• No previous gastric cancer surgery, anti-tumor chemoradiotherapy/immunotherapy;
• ECOG score 0-1;
• Expected survival time \> 6 months;
• Adequate organ function, subject must meet the following laboratory indicators:
• \) absolute neutrophil count (ANC) ≥1.5x109/L without using granulocyte colony-stimulating factor for the past 14 days.
• \. Myocardial enzymes within the normal range (simple laboratory abnormalities without clinical significance judged by the investigators were also allowed to be enrolled); 10. For women of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days before receiving the first dose of study drug (day 1 of cycle 1). If a urine pregnancy test result could not be confirmed as negative, a blood pregnancy test was requested. Women who were not of reproductive age were defined as those who had been postmenopausal for at least 1 year or had undergone surgical sterilization or hysterectomy.
• \. If there was a risk of pregnancy, all subjects (male or female) were required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug on treatment (or 180 days after the last dose of chemotherapy drug).

You may not qualify if:

• Known HER2 positivity;
• Malignant diseases other than gastric cancer (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection in situ carcinoma) diagnosed within 5 years before the first dose;
• Are currently participating in an interventional clinical study treatment, or have received another study drug or investigational device within 4 weeks before the first dose;
• Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent targeting another T-cell receptor that stimulates or coinhibits it (e.g., CTLA-4, OX-40, CD137);
• Active autoimmune disease leading to systemic therapy (e.g., disease-modifying agents, glucocorticoids, or immunosuppressive agents) occurred within 1 year before the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) were not considered systemic therapy;
• Receiving systemic glucocorticoids (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days before the first study dose; Note: Physiologic doses of glucocorticoids (≤10 mg per day of prednisone or equivalent) were allowed.
• Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
• Patients with known allergy to sintilimab, ipilimumab injection N01, chemotherapy active ingredients or excipients;
• Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade ≤1 or baseline, excluding fatigue or alopecia);
• Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive);
• Known signs of active bleeding on endoscopy and a history of gastrointestinal perforation and/or fistula within 6 months;
• Received anti-tumor Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control ascites) with systemic treatment within 2 weeks before the first dose;
• Uncontrolled active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal range in the laboratory of the research center);
• HBV viral load \&lt before the first administration; 1000 copies /ml (200 IU/ml), subjects should receive anti-HBV therapy throughout the study drug treatment to avoid viral reactivation
• For subjects with anti-HBc (+), HBsAg (-), anti-hbs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but viral reactivation should be closely monitored 14. Active HCV-infected subjects (HCV-antibody positive and HCV-RNA level above the lower limit of detection); 15. Received a live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Administration of injectable inactivated virus vaccine against seasonal influenza within 30 days before the first dose is allowed; Live, attenuated, intranasal influenza vaccine was not allowed.

Sponsors & Collaborators

• Chen Lizhu: lead

MeSH Terms

Interventions

sintilimab; XELOX

Central Study Contacts

Lizhu Chen, MD

CONTACT

86+15060035812; yiduoyun037@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 10, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 15, 2030
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share