Safety and Efficacy of Systemic Chemotherapy Plus PD-1 Inhibitor in Combination With Bevacizumab in Gastric Cancer With Peritoneal Metastasis

Phase 2

• Conditions: Gastric Cancer Peritoneal Metastases
• Interventions: Drug: albumin-bound paclitaxel (260 mg/m2, d1); Drug: S-1; Drug: sintilimab; Drug: bevacizumab

• Registration Number: NCT06487715
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

It is an open label, phase II study involved receiving albumin-bound paclitaxel plus S-1 combined with sintilimab and bevacizumab in patients with gastric cancer peritoneal metastasis.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-01
• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• 18 to 75 years patients histologically or cytologically confirmed the presence of GC or gastroesophageal junction tumor with PM (HER2 negative). The ECOG performance status is 0-1 and the expected survival time is more than 3 months. Did not receive any therapy for GC within the last six months (chemotherapy, radiation therapy, or both).

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Exclusion Criteria

• Principal exclusion criteria: The obstruction of the cardia and pylorus affects the patient's eating and gastric emptying, or has difficulty swallowing tablets. HER2-positive GC and gastroesophageal junction tumors. Subject with other malignancies, except for non-melanoma skin cancer or in-situ cervical carcinoma under adequate treatment, or other treated malignancies without evidence of recurrence for 5 years. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co-inhibit T cell receptors (eg, CTLA-4, OX-40, CD137). Received systemic treatment with Chinese medicines or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) with anti-tumor indications within 2 weeks before the first administration; Active autoimmune disease requiring systemic therapy (eg, disease-modifying drugs, glucocorticoids, or immunosuppressants) occurred within 2 years prior to first dose; Replacement therapy (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Albumin-bound paclitaxel plus S1 and sintilimab in combination with Bevacizumab	albumin-bound paclitaxel (260 mg/m2, d1)	Intraperitoneal period: Albumin-bound paclitaxel plus S-1 combined with sintilimab (200 mg, d1) and bevacizumab (7.5 mg/m2, d1) intraperitoneally, 3-week cycle, 2 cycles; Maintenance period: Albumin-bound paclitaxel plus S-1 combined with sintilimab (200 mg, d1) and bevacizumab (7.5 mg/m2, d1) intravenously, 3-week cycle
Albumin-bound paclitaxel plus S1 and sintilimab in combination with Bevacizumab	bevacizumab	Intraperitoneal period: Albumin-bound paclitaxel plus S-1 combined with sintilimab (200 mg, d1) and bevacizumab (7.5 mg/m2, d1) intraperitoneally, 3-week cycle, 2 cycles; Maintenance period: Albumin-bound paclitaxel plus S-1 combined with sintilimab (200 mg, d1) and bevacizumab (7.5 mg/m2, d1) intravenously, 3-week cycle
Albumin-bound paclitaxel plus S1 and sintilimab in combination with Bevacizumab	sintilimab	Intraperitoneal period: Albumin-bound paclitaxel plus S-1 combined with sintilimab (200 mg, d1) and bevacizumab (7.5 mg/m2, d1) intraperitoneally, 3-week cycle, 2 cycles; Maintenance period: Albumin-bound paclitaxel plus S-1 combined with sintilimab (200 mg, d1) and bevacizumab (7.5 mg/m2, d1) intravenously, 3-week cycle
Albumin-bound paclitaxel plus S1 and sintilimab in combination with Bevacizumab	S-1	Intraperitoneal period: Albumin-bound paclitaxel plus S-1 combined with sintilimab (200 mg, d1) and bevacizumab (7.5 mg/m2, d1) intraperitoneally, 3-week cycle, 2 cycles; Maintenance period: Albumin-bound paclitaxel plus S-1 combined with sintilimab (200 mg, d1) and bevacizumab (7.5 mg/m2, d1) intravenously, 3-week cycle

Primary Outcome Measures

Name	Time	Method
Overall survival rate	1 year

Secondary Outcome Measures

Name	Time	Method
Progression free survival	1 year
Ascites drainage-free survival	1 year
Objective Response Rate	1 year

Trial Locations

Locations (1)

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China