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

NCT04888806 | Unknown Phase 2

• 1 other identifier: SHR-1210-HLJ-019
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Colorectal Cancer Metastatic; Liver Metastases; Lung Metastases

Outcome Measures

Primary Outcomes (1)

• 12-month progression-free survival (PFS)

  The date of first treatment until the date of progression using the RECIST 1.1 criteria, or death due to any cause,whichever comes first.

  1 year

Secondary Outcomes (4)

• Objective response rate(ORR)

  3 years

• Disease control rate (DCR)

  3 years

• progression-free survival (PFS)

  3 years

• Overall Survival(OS)

  3 years

Study Arms (1)

Camrelizumab+ablation +chemotherapy

EXPERIMENTAL

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.

Drug: Camrelizumab; Procedure: ablation; Drug: chemotherapy

Interventions

Camrelizumab DRUG

d1，200mg, iv, q3w

Camrelizumab+ablation +chemotherapy

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.

Camrelizumab+ablation +chemotherapy

chemotherapy DRUG

standard treatment plan for mCRC, determined by the investigator

Camrelizumab+ablation +chemotherapy

Eligibility Criteria

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

You may qualify if:

• Two types of imaging or histology/cytology confirmed colorectal cancer patients with liver metastasis/lung metastasis ;
• Must have CT or MRI examination for the past 3 months;
• In addition to ablation lesions, there are measurable metastatic lesions (spiral CT scan ≥10mm, meet mRECIST 1.1 standard);
• Expected survival time\> 3 months;
• Patients who have received at least one prior systemic treatment;
• The damage caused by the subject receiving other treatments has been restored;
• Known KRAS, NRAS, BRAF and HER2 gene status;
• Age: 18 to 70 years old, no gender limit;
• ECOG PS: 0-2 points;
• The functions of vital organs meet the following requirements:
• Absolute neutrophil count ≥1.5×109/L, platelet ≥100×109/L, hemoglobin
• ≥9g/dL;
• Bilirubin ≤1.5 times ULN (can be included in patients drained by retrograde technique); ALT and AST
• ≤5 times ULN
• Creatinine \<120μmol/ L, or MDRD creatinine clearance rate\> 60 mL/min

You may not qualify if:

• Women who are pregnant or breastfeeding, or have fertility but refuse to take contraceptive measures;
• Suffer from other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or skin squamous cell carcinoma, or skin basal cell carcinoma that has been basically controlled;
• Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction;
• Subjects with active, known or suspected autoimmune diseases, hypothyroidism requiring only hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) Can be selected
• Patients with active hepatitis B or C, chronic infection of hepatitis B virus (HBV) or hepatitis C virus (HCV) with a viral load of less than 500 IU/mL are allowed to participate in the study, but need to continue during the study period or start a full-course standardized antiviral treatment;
• Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; or other patients who cannot tolerate surgery;
• Severe active infections that require intravenous antibiotic treatment occurred during the enrollment period;
• Those who are allergic to test drugs;
• Live vaccines have been vaccinated or will be vaccinated within 30 days before the administration of Camrelizumab;
• Patients who cannot comply with the trial protocol or cannot cooperate with follow-up;
• The researcher believes that it is inappropriate to participate in this trial.

Sponsors & Collaborators

• Harbin Medical University: lead

MeSH Terms

Interventions

camrelizumab; Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Yanqiao Zhang, Ph D

CONTACT

13845120210; yanqiaozhang@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 17, 2021
• Study Start: June 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: May 17, 2021

Record last verified: 2021-05