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Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer

ConditionsMetastasis Colorectal CancerColon CancerRectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangzhou University of Traditional Chinese Medicine

About this trial

This is an Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 and ≤ 75 years of age;

Have fully understood and voluntarily sign the ICF for this study (the icf must be signed before any trial-specific procedures are performed);Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;

Histologically and/or cytologically documented metastatic colorectal adenocarcinoma;

Refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan;

Disqualifiers

Pregnant or lactating women;

Any factors that influence the usage of oral administration or any disease or condition that affects drug absorption;

Previous treatment with Tegafur Gimeracil Oteracil ;

Participated in clinical trials of other drugs within four weeks before enrollment;

Trial design

Design model

Single group

Treatments tested in this trial

  • Fuquinitinib+Tegafur Gimeracil Oteracil

    Drug

    Fuquinitinib:5 mg once daily, 2 weeks on/1 week off,q3w; Tegafur Gimeracil Oteracil:BSA(body surface area)\< 1.2m2,40mg/m2,p.o,bid,2 weeks on/1 week off,q3w; 1.2m2 \< BSA （body surface area）\< 1.5m2,50mg/m2,p.o,bid,2 weeks on/1 week off,q3w;BSA（body surface area） \>1.5m2,60mg/m2,p.o,bid,2 weeks on/1 week off,q3w;

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: Fuquinitinib +Tegafur Gimeracil OteracilExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator

Time frame
from randomization up to progressive disease or EOT due to any cause, up to 2 years

Secondary outcomes

1

Objective response rate(ORR)

Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.

Time frame
from randomization up to progressive disease or EOT due to any cause, up to 2 years
2

Disease control rate(DCR)

DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator

Time frame
from randomization up to progressive disease or EOT due to any cause, up to 2 years
3

Overall survival (OS)

OS is the time from enrollment to death due to any cause.

Time frame
from randomization up to progressive disease or EOT due to any cause, up to 3 years
4

adverse events (AE)

overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.

Time frame
from day 1 of first dosing to 30days after permanent discontinuation of fruquintinib

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou University of Traditional Chinese Medicine

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: