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

NCT06487715 | Enrolling By Invitation Phase 2

• 1 other identifier: UNION-GCPM
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer Peritoneal Metastases

Outcome Measures

Primary Outcomes (1)

• Overall survival rate

  1 year

Secondary Outcomes (3)

• Progression free survival

  1 year

• Ascites drainage-free survival

  1 year

• Objective Response Rate

  1 year

Study Arms (1)

Albumin-bound paclitaxel plus S1 and sintilimab in combination with Bevacizumab

EXPERIMENTAL

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); Drug: S-1; Drug: sintilimab; Drug: bevacizumab

Interventions

albumin-bound paclitaxel (260 mg/m2, d1) DRUG

260 mg/m2, d1)

Albumin-bound paclitaxel plus S1 and sintilimab in combination with Bevacizumab

S-1 DRUG

80 mg/m2, d1-14

Albumin-bound paclitaxel plus S1 and sintilimab in combination with Bevacizumab

sintilimab DRUG

200 mg, d1

Albumin-bound paclitaxel plus S1 and sintilimab in combination with Bevacizumab

bevacizumab DRUG

First two cycles : intraperitoneally 7.5 mg/m2 Maintenance period: intravenously 7.5 mg/m2

Albumin-bound paclitaxel plus S1 and sintilimab in combination with Bevacizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Interventions

Albumin-Bound Paclitaxel; S 1 (combination); sintilimab; Bevacizumab

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Design

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

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)