Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab as Second-line Treatment in MSS Type Metastatic Colorectal Cancer Based on RAS Gene Status

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Evaluate the objective response rate (ORR) of AK104 combined with chemotherapy and cetuximab or bevacizumab in second-line treatment of MSS type advanced colorectal cancer

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 1\. Voluntarily sign a written ICF. 2. Age at enrollment: ≥ 18 years old, ≤ 75 years old, both male and female. 3. The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.

• 4\. The expected survival period is ≥ 3 months. 5. Metastatic colorectal adenocarcinoma confirmed by histology or cytology. 6. Microsatellite instability (MSI) status is MSI-L or MSS type human. 7. The metastatic lesion cannot be removed and is not suitable for curative surgical treatment.

• 8\. Previously only received first-line systemic anti-tumor therapy based on oxaliplatin (FOLFOX or CAPOX), and other systemic anti-tumor treatments for metastatic colorectal cancer are not allowed. Note: For subjects who have previously received neoadjuvant therapy, adjuvant therapy, or curative radiotherapy and chemotherapy, if disease progression occurs during or within 6 months after treatment, it is considered that they have received first-line treatment.

⁃ According to RECIST v1.1, subjects must have at least one measurable lesion. For subjects who have previously received radiotherapy, if there are no other lesions that can be selected as target lesions and there is objective evidence of significant progression after radiotherapy, the irradiated lesions can be considered as target lesions.

⁃ 10\. The subjects are required to provide 15 recently archived or freshly obtained FFPE pathological sections of tumor tissue.

⁃ 11\. Determine good organ function through the following requirements:

⁃ a) Hematology (no use of any blood components or cell growth factor branches within 7 days prior to starting treatment)

⁃ Holding treatment:

⁃ i. Neutrophil absolute value ANC ≥ 1.5 × 109/L (1500/mm3); Ii. Platelet count ≥ 100 × 109/L (100000/mm3); Iii. Hemoglobin ≥ 90 g/L. b) Kidney: i. The calculated value of creatinine clearance rate \* (CrCl) is ≥ 50 mL/min

⁃ \*The Cockcroft Fault formula will be used to calculate CrCl (Cockcroft Fault formula) CrCl (mL/min)={(140- age) × Weight (kg) × F} /(SCr (mg/dL) × 72) F=1 for males; F=0.85 for women; SCr=serum creatinine. Ii Urinary protein ≤ 1+or 24-hour (h) urinary protein quantification\<1.0 g. c) Liver: i. Total serum bilirubin (TBil) ≤ 1.5 × ULN; For liver metastasis or evidence to confirm/suspect Subjects with Gilbert disease, TBil ≤ 3 × ULN Ii. AST and ALT ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT ≤ 5 × ULN Iii. Serum albumin (ALB) ≥ 28 g/L d) Coagulation function: i. International Standardization Ratio

Locations
Other Locations
China
the Second Affiliated Hospital of Medical College of Zhejiang University
RECRUITING
Hangzhou
the Second Affiliated Hospital of Medical College of Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Xuefeng Fang, Dr
xffang@zju.edu.cn
0571-87784718
Time Frame
Start Date: 2024-01-03
Estimated Completion Date: 2027-01-03
Participants
Target number of participants: 40
Treatments
Experimental: AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab
AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov