drugset / Trial / NCT05372198

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

NCT05372198

Phase 2 Unknown 50 enrolled Hubei Cancer Hospital
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2022-03-30
Primary completion
2024-01
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Surufatinib Small molecule 250 mg
Subject Surufatinib Small molecule 300 mg

Indications