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Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer

ConditionAdvanced Endometrial Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorHutchmed

About this trial

The goal of this study is to evaluate whether fruquintinib(HMPL-013) plus sintilimab(IBI308) is safe and effective in the treatment of advanced endometrial cancer(EMC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have fully understood and voluntarily signed the informed consent form

Age 18 to 75 years (inclusive) ; Body mass index (BMI) ≥ 18.5kg/m²;

Histologically or cytologically confirmed advanced or recurrent endometrial cancer with measurable lesions

Patients who previously failed first-line systemic platinum-based therapy

Disqualifiers

Endometrial carcinosarcoma or sarcoma;

Known MMR(mismatch repair)/MSI status with dMMR(deficient mismatch repair) or MSI-H(microsatellite instability-high);

Toxicities related to prior anticancer therapy did not recover to ≤CTCAE Grade 1, except alopecia and oxaliplatin-induced peripheral neurotoxicity ≤CTCAE Grade 2;

Received systemic anti-tumor therapy approved within 4 weeks before randomization;

Trial design

Design model

Parallel

Treatments tested in this trial

  • fruquintinib

    Drug

    Fruquintinib will be orally administrated once daily for 2 consecutive weeks followed by a 1-week break.

  • sintilimab

    Biological/Vaccine

    Sintilimab will be intravenously administrated on Day 1 every three weeks.

  • paclitaxel

    Drug

    175 mg/m\^2 via IV infusion, once a week for 3 weeks followed by a 1-week break.

  • doxorubicin

    Drug

    60mg/m\^2 via IV infusion, on Day 1 every three weeks.

Treatment groups

412 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS) as assessed by IRC

Progression-free survival (PFS) is defined as the time from randomization to disease progression assessed by IRC or death due to any cause, whichever occurs first.

Time frame
Up to approximately 4 years
2

Overall Survival (OS)

Overall Survival (OS) is defined as the time from randomization to death due to any cause.

Time frame
Up to approximately 4 years

Secondary outcomes

1

Objective Response Rate (ORR)

Objective Response Rate (ORR) is defined as the ratio of patients who reached complete response (CR) or partial response (PR) , as assessed by IRC and investigator.

Time frame
Up to approximately 4 years
2

Duration of Response (DoR)

For patients who reached complete response (CR) or partial response (PR), Duration of Response (DoR) is defined as the time from the first CR or PR until disease progression or death due to any cause, whichever occurs first ,as assessed by IRC and investigator.

Time frame
Up to approximately 4 years
3

Disease Control Rate (DCR)

Disease Control Rate (DCR) is defined as the ratio of patients who reached complete response (CR) or partial response (PR) or maintained a stable disease, as assessed by IRC and investigator.

Time frame
Up to approximately 4 years
4

Time To Response (TTR)

Time To Response (TTR) is defined as the time from the start of treatment to the first objective response rate (ORR) ,as assessed by IRC and investigator.

Time frame
Up to approximately 4 years

Other outcomes

Sponsors and contacts

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

Hutchmed

Lead sponsor

Source ClinicalTrials.gov
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