An Exploratory Trail of Camrelizumab Plus Apatinib Mesylate for Advanced Gastrointestinal

Sponsor
Harbin Medical University
Study ID
NCT05225844
Phase
PHASE2
Status
Unknown

Conditions

  • Gastrointestinal Cancer
  • Immunotherapy
  • Targeted Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Camrelizumab ，200mg/㎡，d1，ivgtt，every 21 days as a cycle
  • Apatinib Mesylate — DRUG
    Apatinib Mesylate，250mg/㎡，po，d1-5 on/d2 off，every 21 days as a cycle

Study Details

At present, surgery, radiotherapy and chemotherapy are the main treatment methods for patients with advanced gastrointestinal cancer. Although targeted therapy has significantly improved the prognosis of patients, the mortality of patients has not been significantly reduced, so new treatment methods are urgently needed. In recent years, immunotherapy has become a new hotspot in tumor therapy. Compared with traditional treatment, immune checkpoint inhibitors (ICIS) have shown long-term good efficacy and tolerance in clinical trials. However, single drug ICIS has reached a bottleneck for advanced gastrointestinal cancer, with low response rate and poor PFS and OS. With the results of REGONIVO showing good efficacy, the treatment mode of immune combined with small molecule anti angiogenesis drugs has sprung up. The purpose of this study was to analyze the efficacy and safety of in Camrelizumab combination with Apatinib mesylate in advanced gastrointestinal cancer.

Key Dates

Start date
Jan 1, 2019
Status verified
Feb 2022
Primary completion
Feb 1, 2022
Completion
Oct 1, 2022

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab Plus Apatinib mesylate
    for advanced gastric cancer with previous standard treatment failure
  • Experimental: Camrelizumab and Apatinib mesylate
    for advanced colorectal cancer with previous standard treatment failure

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 24 months ]

Central Contacts

Related Studies