A Single-arm, Open-label, Phase Ⅱ Clinical Trial of Adebrelimab Plus Cetuximab and Chemotherapy for Patients With RAS/BRAF Wild-Type Unresectable Liver Metastases Colorectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Adebrelimab + Cetuximab+ Chemotherapy
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- The First Affiliated Hospital of Zhengzhou University
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to observe and evaluate the efficacy and safety of adebrelimab plus cetuximab and chemotherapy for patients with RAS/BRAF wild-type unresectable liver metastases colorectal cancer.
Detailed Description
Colorectal cancer is the third largest malignant tumor in the world and a significant cause of cancer-related deaths. The probability of simultaneous liver metastasis in colorectal cancer is about 25%, and the proportion of liver metastasis occurring in the entire disease process is as high as 40% -50%. It is of great clinical significance to transform the initial unresectable liver metastases of colorectal cancer into resectable ones to improve the overall survival rate and prognosis of colorectal cancer patients. We designed a single-arm, open phase II clinical trial of adebrelimab plus cetuximab and chemotherapy for patients with RAS/BRAF wild-type unresectable liver metastases colorectal cancer. The purpose of this study is to observe and evaluate the efficacy and safety of adebrelimab plus cetuximab and chemotherapy for patients with RAS/BRAF wild-type unresectable liver metastases colorectal cancer.
Investigators
Hong Zong
A Single-arm, Open-label, Phase Ⅱ Clinical Trial of Adebrelimab Plus Cetuximab and Chemotherapy for Patients With RAS/BRAF Wild-Type Unresectable Liver Metastases Colorectal Cancer
The First Affiliated Hospital of Zhengzhou University
Eligibility Criteria
Inclusion Criteria
- •Patients who have fully understood and voluntarily signed informed consent forms for this study, have good compliance, and cooperate with follow-up;
- •Age ≥ 18 years and ≤ 75 years old;
- •Expected survival time ≥ 12 weeks;
- •Patients confirmed by histology or pathology to have colon or rectal glands;
- •Primary or metastatic tumors of the colon are identified as RAS/BRAF wild-type;
- •PET/CT scan, CT scan, MRI or intraoperative exploration diagnosis (if applicable during resection of primary colorectal tumor), record evidence of limited liver metastasis in the patient (histological confirmation of liver metastasis is not required);
- •Primary colorectal cancer can be or has been radically resected, initial inability to R0 resection of liver metastases, or residual liver volume ≤ 30-40% after resection;
- •The patient has at least one measurable liver metastasis lesion (according to RECIST 1.1 standard);
- •There was no previous liver metastasis chemotherapy;
- •The main organ function is normal, which meets the following criteria:
Exclusion Criteria
- •Patients who had any of the following symptoms were excluded from the study:
- •Individuals who are allergic to treatment drugs;
- •Patients who have received standard treatment for liver metastasis colorectal cancer;
- •Previously received anti-tumor therapy or radiation therapy for any malignant tumor;
- •Simultaneously receiving anti-tumor therapies in other clinical trials, including endocrine therapy, bisphosphate therapy, or immunotherapy;
- •Has undergone significant surgical procedures unrelated to colorectal cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures;
- •Patients with extrahepatic metastasis, unresectable lymph nodes (including portal vein lymph nodes) metastasis, and primary tumor recurrence;
- •Patients whose imaging shows that the tumor has invaded important blood vessels or who have been determined by the researchers to be highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies
- •Within 5 years, subjects have had or co-developed other malignancies requiring active treatment
- •Existence of active autoimmune diseases or immunodeficiency, or a history of autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituitary inflammation, vasculitis, nephritis, etc.
Arms & Interventions
Adebrelimab + Cetuximab+ Chemotherapy
Adebrelimab + Cetuximab+ Chemotherapy
Intervention: Adebrelimab + Cetuximab+ Chemotherapy
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: up to 1 year
The ration of patients who are evaluated as CR or PR
Secondary Outcomes
- Adverse events (Safety）(up to 2 years)
- Progression free survival (PFS)(up to 2 years)
- The R0 resection rates The R0 resection rates(1 year)
- Overall survival (OS)(up to 2 years)