NCT06238752

First-line Apatinib Combined With Tislelizumab and Chemotherapy for Advanced GC

First-line Apatinib Combined With Tislelizumab and Chemotherapy for Advanced Gastric and Gastroesophageal Junction(G/GEJ) Adenocarcinoma Patients With Poor Prognosis: A Prospective Exploratory Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Renmin Hospital of Wuhan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this clinical study, investigators explore the efficacy and safety of a combination therapy regimen with antiangiogenic agent (apatinib), ICI (tislelizumab), and chemotherapy (capecitabine+ Oxaliplatin, XELOX) as first-line treatment for HER2-negative, advanced G/GEJ cancer patients with signet ring cell carcinoma or peritoneal metastasis.

Detailed description

Patients received 8 cycles of apatinib (250 mg, qd, d1-14), tislelizumab (200 mg d1), and oxaliplatin (130 mg/m2, d1) plus oral capecitabine (1000 mg/m2, bid, d1-14) every 3 weeks, with a maintenance therapy with apatinib plus tislelizumab for a maximum of 1 year. Homogeneous patients receiving ICIs combined with chemotherapy at the same time were deemed as the control group for efficacy.

Conditions

• Advanced Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Apatinib Combined With Tislelizumab and Chemotherapy	apatinib (250 mg, qd, d1-14), tislelizumab(200 mg d1), and oxaliplatin (130 mg/m2, d1) plus oral capecitabine (1000 mg/m2, bid, d1-14) every 3 weeks

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-03-01
• Completion: 2024-01-01
• First posted: 2024-02-02
• Last updated: 2024-02-02

Locations

1 site across 1 country: China