A Trial of Camrelizumab Combined With Microwave Ablation and Chemotherapy in the Treatment of Colorectal Cancer Liver Metastasis/Pulmonary Metastasis

Sponsor
Harbin Medical University
Study ID
NCT04888806
Phase
PHASE2
Status
Unknown

Conditions

  • Colorectal Cancer Metastatic
  • Liver Metastases
  • Lung Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    d1，200mg, iv, q3w
  • ablation — PROCEDURE
    the 37 enrolled patients received ablation of liver/lung metastases ，If the patient has multiple metastatic tumors, ablation therapy needs to be performed in multiple times.
  • chemotherapy — DRUG
    standard treatment plan for mCRC, determined by the investigator

Study Details

Currently, comprehensive treatments for liver metastasis/pulmonary metastasis that cannot reach NED include systemic chemotherapy, interventional chemotherapy, molecular targeted therapy, immunotherapy, and local treatments (ablation therapy, radiation therapy, etc.) for liver metastases. Combination therapy model of local ablation, systemic chemotherapy, and anti-PD -1 monoclonal antibody hopefully can prolong patient survival. This trial will evaluate the effectiveness and safety of carrelizumab combined with microwave ablation and chemotherapy in the treatment of colorectal cancer liver metastasis/pulmonary metastasis

Key Dates

Start date
Jun 1, 2021
Status verified
May 2021
Primary completion
Jun 30, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab+ablation +chemotherapy
    The enrolled patients received ablation of liver metastases/pulmonary metastasis first, followed by chemotherapy (standard treatment plan for advanced colorectal cancer, determined by the investigator) and camrelizumab treatment (200mg, iv, q3w) one week later. If the patient has multiple metastatic tumors, ablation therapy needs to be performed in multiple times. Sequential chemotherapy and camrelizumab is administered one week after each ablation therapy. Treatment will continue until disease progression, unacceptable toxicity, or voluntary patient withdrawal.

Primary Outcome Measure

12-month progression-free survival (PFS) [ Time Frame: 1 year ]

Central Contacts

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