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

NCT05372198 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-11-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hubei Cancer Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2024-01-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05372198 on ClinicalTrials.gov