NCT06543836

ctDNA-guided Treatment of TKI Plus PD-1 Inhibitor for Advanced pMMR/MSS Colorectal Cancer

ctDNA-guided Treatment of an Anti-angiogenic TKI Combined With a PD-1 Inhibitor for Advanced pMMR/MSS Colorectal Cancer Failed With Standard Therapy: a Randomized Controlled Phase 2 Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The efficacy of combining TKI with PD-1 inhibitor in the treatment of advanced MSS/pMMR colorectal cancer with low levels of maxVAF in peripheral blood ctDNA failed with standard treatment was assessed, compared to standard treatment as chosen by researchers.

Detailed description

This study is a prospective, randomized phase II controlled trial. It will include patients with histologically confirmed advanced metastatic pMMR/MSS colorectal adenocarcinoma, who have failed with treatment with fluoropyrimidine (5-fluorouracil or capecitabine), oxaliplatin, irinotecan plus bevacizumab/cetuximab (left-side RAS/BRAF wild-type) and whose peripheral blood ctDNA test shows a maxVAF level lower than 6.5%. Patients will be randomly assigned to receive a TKI + a PD-1 inhibitor (primarily fruquintinib combined with sintilimab) or standard later-line treatment options (regorafenib or fruquintinib monotherapy, at the discretion of the investigator) until disease progression, death, intolerable adverse events, or withdrawal of informed consent.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab 200mg, d1, with a treatment cycle of 21 days, and efficacy assessment every 2 cycles.
DRUG	Fruquintinib or Regorafenib	The treatment regimen consists of the following options: Option 1: Fruquintinib 5mg Qd, d1-21, Q4w, and efficacy assessment every 1.5 months. Option 2: Regorafenib 160mg Qd, d1-21, Q4w, and efficacy assessment every 1.5 months.
DRUG	Fruquintinib	Fruquintinib 5mg Qd, d1-14, with a treatment cycle of 21 days, and efficacy assessment every 2 cycles.

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: China