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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gastric Cancer Peritoneal Metastases
• Intervention / Treatment: Drug: albumin-bound paclitaxel (260 mg/m2, d1); Drug: S-1; Drug: sintilimab; Drug: bevacizumab

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Albumin-bound paclitaxel plus S1 and sintilimab in combination with 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

Drug: albumin-bound paclitaxel (260 mg/m2, d1); 260 mg/m2, d1); Drug: S-1; 80 mg/m2, d1-14; Drug: sintilimab; 200 mg, d1; Drug: bevacizumab; First two cycles : intraperitoneally 7.5 mg/m2 Maintenance period: intravenously 7.5 mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival rate	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	1 year
Objective Response Rate	1 year
Ascites drainage-free survival	1 year

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Stomach Neoplasms; Neoplasm Metastasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Paclitaxel; Bevacizumab; Albumin-Bound Paclitaxel
• Other Study ID Numbers: UNION-GCPM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No