MedTrace Logo

Phase II Trial of Fruquintinib With Sintilimab in Treating Selected Refractory Metastatic Colorectal Cancer Patients

NCT04695470 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-01-07

No results posted yet for this study

Summary

This is a prospective, Single arm Phase II trial. Patients were eligible to participate when they had histological or cytological confirmed metastatic colorectal adenocarcinoma Non-MSI(microsatellite instability)-high and TMB(tumor mutational burden)-High.

Patients had to have received at least a second-line standard therapy, including fluoropyrimidine, oxaliplatin, or irinotecan-based regimens and VEGF(vascular endothelial growth factor) inhibitors and to have disease progression within 3 months after the last administration of the last standard therapy or to have stopped such therapy due to unacceptable toxicities. Pre-treatment with anti-EGFR(epidermal growth factor receptor) were mandatory if RAS(Rat sarcoma virus) wild and left side .

Patients who met the eligibility criteria took fruquintinib plus Sintilimab 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) rate at 6 months.

Conditions

Interventions

DRUG

Fruquintinib and Sintilimab

fruquintinib 5mg qd for 2 weeks on and 1 week off, Q3w Sintilimab 200mg iv, Q3w

Sponsors & Collaborators

  • Aiping Zhou

    lead UNKNOWN

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04695470 on ClinicalTrials.gov