Adebrelimab Plus Cetuximab and Chemotherapy for Patients With RAS/BRAF Wild-Type Unresectable Liver Metastases Colorectal Cancer

NCT06231017 | Unknown Phase 2

• 1 other identifier: S2023-K019-003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  The ration of patients who are evaluated as CR or PR

  up to 1 year

Secondary Outcomes (4)

• Progression free survival (PFS)

  up to 2 years

• Overall survival (OS)

  up to 2 years

• The R0 resection rates The R0 resection rates

  1 year

• Adverse events (Safety）

  up to 2 years

Study Arms (1)

Adebrelimab + Cetuximab+ Chemotherapy

EXPERIMENTAL

Adebrelimab + Cetuximab+ Chemotherapy

Drug: Adebrelimab + Cetuximab+ Chemotherapy

Interventions

Adebrelimab + Cetuximab+ Chemotherapy DRUG

Adebrelimab:1200 mg, D1, Q2W+Cetuximab:500 mg, D1, Q2W+FOLFOX6(Q2W) or FOLFIRI(Q2W) until PD or resectability or to max 12 cycles

Adebrelimab + Cetuximab+ Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients who have fully understood and voluntarily signed informed consent forms for this study, have good compliance, and cooperate with follow-up; 2. Age ≥ 18 years and ≤ 75 years old; 3. ECOG 0-1; 4. Expected survival time ≥ 12 weeks; 5. Patients confirmed by histology or pathology to have colon or rectal glands; 6. Primary or metastatic tumors of the colon are identified as RAS/BRAF wild-type; 7. 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); 8. 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; 9. The patient has at least one measurable liver metastasis lesion (according to RECIST 1.1 standard); 10. There was no previous liver metastasis chemotherapy; 11. The main organ function is normal, which meets the following criteria:
• Blood routine examination criteria should be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors):
• A. Hemoglobin (Hb) ≥ 90 g/L; B. Neutrophil count (ANC) ≥ 1.5 × 109/L; C. Platelet count (PLT) ≥ 100 × 109/L;
• Biochemical examination must meet the following standards:
• A. Total bilirubin (TBIL)\<1.5 upper limit of normal value (ULN); B. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are less than 2.5 ULN, while for patients with liver metastasis, they are less than 5 ULN; C. Serum creatinine (Cr) ≤ 1.5 ULN or endogenous creatinine clearance rate\>60ml/min (Cockcroft Gault formula); D. The urine routine test results show that urine protein (UPRO)\<2+or 24-hour urine protein quantification\<1g;
• Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%);
• Coagulation function: International standardized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time ≤ 1.5 × ULN;
• Pulmonary function: First second forced expiratory volume (FEV1) ≥ 1.2 L, FEV1% ≥ 50%, carbon monoxide diffusion volume (DLCO) ≥ 50%;
• Other: lipase ≤ 1.5 × ULN (if lipase\>1.5) × ULN can be included if there is no clinical or imaging confirmation of pancreatitis; Amylase ≤ 1.5 × ULN (if amylase\>1.5 × ULN can be included if there is no clinical or imaging confirmation of pancreatitis; Alkaline phosphatase (ALP) ≤ 2.5ULN.
• Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period;

You may not qualify if:

• 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.
• Individuals who test positive for HIV or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or allogeneic hematopoietic stem cell transplantation. The following exceptions apply: Patients with a history of autoimmune hypothyroidism who have received thyroid hormone replacement therapy may be included in the study. Patients with type 1 diabetes whose blood sugar can be controlled after treatment with insulin administration scheme can participate in this study.
• The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage\>10mg/day prednisone or other therapeutic hormones) and continues to use them within 2 weeks prior to enrollment;
• Patients who have received systemic treatment with high-dose antibiotics within the past 2 weeks;
• Individuals who have experienced arterial/venous thrombosis events within 6 months prior to the first administration, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, and pulmonary embolism;
• Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting surgery within 6 months prior to enrollment; Congestive heart failure: New York Heart Association (NYHA) grade ≥ 2; Ventricular arrhythmia requiring medication treatment (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females); Left ventricular ejection fraction (LVEF)\<50%;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Hong Zong

CONTACT

13523586882; zonghong522@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: 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

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: January 30, 2024
• Study Start: January 19, 2024
• Primary Completion: January 19, 2025
• Study Completion: January 19, 2026
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)