NCT05372198

Surufatinib With or Wothout Immunotherapy for Advanced Colorectal Cancer in Later Line

A Single-center, Open-label, Cohort Study of Surufatinib With or Without Immunotherapy in Patients With Advanced Colorectal Cancer Who Have Failed Front-line Antiangiogenic TKI Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hubei Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open-label, cohort clinical study to investigate the efficacy and safety of surufatinib with or without immunotherapy in patients with advanced colorectal cancer who failed front-line anti-angiogenic TKI therapy. Patients have to received at least a second-line standard therapy or cannot tolerate other treatments, and have previously failed anti-angiogenic TKIs therapy(including but not limited to: fruquintinib/regorafenib/anlotinib) / apatinib, and are resistant to treatment, disease progression, intolerable toxicity or no continued benefit as assessed by investigator after therapy). Patients who met the eligibility criteria are randomized 1:2 into two cohorts (cohort 1: surufatinib, cohort 2: surufatinib plus immunotherapy) to receive treatment until disease progression, death, unacceptable toxicity, withdrawal of consent by the patient, or decision by the treating physician that discontinuation would be in the patient's best interest. The primary study endpoint was PFS(progression free survival).

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	Chohort 1: Surufatinib	Surufatinib 300mg, qd, every 3 weeks as a cycle
DRUG	Chohort 2: Immunotherapy	Refer to the instructions for the use of immunotherapy, every 3 weeks as a cycle
DRUG	Chohort 2: Surufatinib	Surufatinib 250mg, qd, every 3 weeks as a cycle

Timeline

• Start date: 2022-03-30
• Primary completion: 2024-01-01
• Completion: 2024-12-01
• First posted: 2022-05-12
• Last updated: 2022-11-09

Locations

1 site across 1 country: China