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FH-006 Versus Investigator's Choice of Chemotherapy in Patients With Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma Who Have Failed Prior PD-1/PD-L1 Inhibitor Combined With Platinum-Based Chemotherapy.

ConditionLocally Advanced, Recurrent or Metastatic ESCC Patients Who Have Failed Prior PD-1/PD-L1 Inhibitors Combined With Platinum-based Chemotherapy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

The study compares the overall survival (OS) of FH-006 and the second-line chemotherapy selected by the investigators for treating esophageal squamous cell carcinoma patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years old (including boundary values)

Volunteer to participate in this clinical study and sign informed consent;

ECOG score 0-1;

Expected survival ≥3 months;

Disqualifiers

Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study

Toxicities caused by previous anticancer therapy were not recovered to CTCAE 6.0 Grade≤1;

Individuals with Leptomeningeal metastasis or Active brain metastases;

Individuals with a history of GI perforation or fistula, unstable GI bleeding;

Trial design

Design model

Parallel

Treatments tested in this trial

  • FH-006

    Drug

    FH-006

  • Paclitaxel, Docetaxel, Irinotecan

    Drug

    Paclitaxel, Docetaxel, Irinotecan

Treatment groups

480 Participants
are divided into 2 treatment groups
Group A: Treatment group A: FH-006Experimental treatment 1 intervention
Group B: Treatment group B: Paclitaxel, Docetaxel, Irinotecan.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival

Measure description: Defined as time from randomization until the date of death due to any cause

Time frame
Until death, assessed up to approximately 2 years

Secondary outcomes

1

Progression-free survival (PFS) by investigator assessment

Measure description: Defined as time from randomization until progression or death as assessed by the investigator

Time frame
Until progression or death, assessed up to approximately 1 year
2

Objective response rate (ORR) by investigator assessment

Measure description: Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator

Time frame
Until progression, assessed up to approximately 1 year
3

Duration of response (DOR) by investigator assessment

Measure description: Defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death assessed by the investigator

Time frame
Until progression or death, assessed up to approximately 1 year
4

Disease control rate (DCR) by investigator assessment

Measure description: Defined as percentage of participants who achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD) assessed by the investigator

Time frame
Until progression, assessed up to approximately 1 year

Other outcomes

Sponsors and contacts

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

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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