A Phase II/III Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT05945901
Phase
PHASE2/PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab — DRUG
    HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 8-12 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first)
  • HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab — DRUG
    HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 8-12 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first)

Study Details

This is a double-blind, randomized, multi-center, II/III study in at least 606 patients with advanced colorectal cancer. The study is being conducted to evaluate the safety of HR070803 combined with oxaliplatin, 5-FU/LV and bevacizumab in phase II and to evaluate the efficacy of HR070803 in combination with oxaliplatin, 5-FU/LV, and bevacizumab versus HR070803 simulator in combination with FOLFOX and bevacizumab for first-line treatment of patients with unresectable metastatic colorectal cancer.

Key Dates

First listed
Jul 14, 2023
Start date
Aug 14, 2023
Status verified
Jul 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2026

Study Design

Enrollment
669 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HR070803
    HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab
  • Placebo Comparator: HR070803 simulator
    HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab

Primary Outcome Measure

Adverse Events (AE) According to NCI-CTCAE v5.0（Phase II） [ Time Frame: From Baseline to primary completion date, about 48 months ]

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