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

Sponsor
Renmin Hospital of Wuhan University
Study ID
NCT06238752
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 1, 2021
Status verified
Jan 2024
Primary completion
Mar 1, 2023
Completion
Jan 1, 2024

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: first-line treatment with the combination of apatinib, immune checkpoint inhibitor and chemotherapy
    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.

Primary Outcome Measure

PFS [ Time Frame: through study completion, an average of 1 year ]

Related Studies