First-line Maintenance of OH2 Injection for Advanced Colorectal Cancer

Sponsor
Binhui Biopharmaceutical Co., Ltd.
Study ID
NCT05648006
Phase
PHASE2
Status
Terminated

Conditions

  • Advanced Colorectal Carcinoma

Eligibility Criteria

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

Interventions

  • OH2 — BIOLOGICAL
    Oncolytic Type 2 Herpes Simplex Virus
  • Capecitabine — DRUG
    1000 mg/m2, orally administered twice a day, D1 to D14, repeated every 3 weeks
  • Bevacizumab — DRUG
    Bevacizumab: 7.5 mg/kg, intravenously, once every 3 weeks.

Study Details

This is a prospective, multicenter, open, randomized controlled Phase II clinical study to evaluate the efficacy and safety of intratumoral injection of OH2 combined with capecitabine for first-line maintenance of advanced colorectal cancer.

Key Dates

First listed
Dec 13, 2022
Start date
Oct 17, 2023
Status verified
Apr 2024
Primary completion
Apr 15, 2024
Completion
Apr 15, 2024

Study Design

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

Arms

  • Experimental: OH2+Capecitabine
    OH2: 10\^7 CCID50/mL intratumoral injection, once every 2 weeks; Capecitabine: 1000 mg/m2, orally administered twice a day, D1 to D14, repeated every 3 weeks
  • Active Comparator: Capecitabine/Capecitabine+Bevacizumab
    Capecitabine: 1000 mg/m2, orally administered twice a day, D1 to D14, repeated every 3 weeks Bevacizumab: 7.5 mg/kg, intravenously, once every 3 weeks.

Primary Outcome Measure

Progression-free survival [ Time Frame: 2 years ]

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