Efficacy and Safety of Trifluridine/Tipiracil Combined With Fufuquitinib for Third-line Treatment of mCRC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Wenzhou Medical University

About this trial

To evaluate the efficacy and safety of trifluridine/tipiracil combined with fufuquitinib versus trifluridine/tipiracil and fufuquitinib in patients with unresectable metastatic colorectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Age 18-75 (at the time of signing the informed consent);ECOG PS score: 0-1; Expected survival time > 3 months.

Hemoglobin ≥90g/L;Absolute count of neutrophils (ANC) ≥1.5×109/L;Platelet ≥100×109/L;

ALT and AST≤2.5 upper limit of normal (ULN).ALP≤2.5 ULN;(if liver metastases ≤5 ULN);

Total bilirubin (TBIL) < 1.5 ULN;

Disqualifiers

1.Combined disease or history

.Present or present with other malignancies within 3 years.

.Have multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, or intestinal obstruction)

.Gastrointestinal bleeding or perforation occurred during the first 4 weeks of enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • trifluridine/tipiracil combined with fufuquitinib

    Drug

    trifluridine/tipiracil combined with fufuquitinib

  • fufuquitinib

    Drug

    fufuquitinib

  • Trifluridine/tipiracil

    Drug

    Trifluridine/tipiracil

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control Group 1Active comparator 1 intervention
Group C: Control Group 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival

Time frame
up to 24 weeks

Secondary outcomes

1

Total survival time

Time frame
up to 2 years

Other outcomes

Sponsors and contacts

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