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NOT YET RECRUITING
NCT06753721
PHASE1/PHASE2

An Open-label, Multicenter, Single-arm Clinical Study on the Use of Doxorubicin Liposome in Combination With CapOX and Bevacizumab Regimen for First-line Treatment of Advanced Colorectal Adenocarcinoma With SMAD4R361H/C Mutation.

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm clinical study designed to evaluate the 6-month progression-free survival rate (6-month PFS rate) of Doxorubicin liposome combined with CapOX and Bevacizumab regimen as first-line treatment for advanced colorectal adenocarcinoma with SMAD4R361H/C mutation. The study plans to recruit 13 patients. After receiving 8 cycles of induction therapy, patients whose efficacy is evaluated as complete response (CR), partial response (PR), or stable disease (SD) (according to RECIST 1.1) will enter maintenance therapy.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

13

Start Date

2024-12-31

Completion Date

2027-06-01

Last Updated

2024-12-31

Healthy Volunteers

No

Interventions

DRUG

Doxorubicin liposome combined with CapOX and Bevacizumab

Bevacizumab (7.5 mg/kg, IV, Day 1) + Oxaliplatin (130 mg/m², IV, Day 1) + Capecitabine (1000 mg/m², oral, twice daily, for 14 days) + Doxorubicin liposome (20 mg/m², IV, Day 1), repeated every 3 weeks.