Irinotecan Plus Anlotinib or Further in Combination With Penpulimab for Second-line Treatment of mCRC

Sponsor
Fudan University
Study ID
NCT05229003
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Anlotinib — DRUG
    Anlotinib 8mg or 10mg, d1-9，q2w
  • Penpulimab — DRUG
    Penpulimab 200mg, d6, q2w
  • Irinotecan — DRUG
    Irinotecan 180mg/m2, d6, q2w

Study Details

This is an exploratory, non-controlled, multi-cohort, phase II small-sample clinical study designed to evaluate the clinical benefit of second-line treatment with anlotinib plus irinotecan or further in combination with a PD-1 monoclonal antibody (penpulimab) in patients with advanced colorectal cancer after first-line treatment failure. To explore the rationality of the combination of chemotherapy and targeted therapy and immunotherapy strategy and obtain relevant survival and safety data. The study will fully evaluate the efficacy, PFS, OS, safety and related biomarkers of the regimen.

Key Dates

Start date
Mar 9, 2022
Status verified
Jul 2024
Primary completion
May 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
44 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: cohort A
    Anlotinib + Irinotecan: Anlotinib, 10mg, oral, once daily, D1-10, q2W; Irinotecan, 180mg/m2, iv drip, d6, q2w.
  • Experimental: cohort B
    Anlotinib + Penpulimab + Irinotecan: Anlotinib, 8mg, oral, once daily, d1-10, q2w; Penpulimab 200mg, i.v. d6, q2w; Irinotecan, 180mg/m2, iv infusion, d6, q2w.

Primary Outcome Measure

ORR [ Time Frame: the rate of patients with CR and PR, through study completion, an average of 1 year ]

Central Contacts

Related Studies