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.

August 25, 2026 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Randomized, Open-label, Multicenter, Phase III Study of 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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Provincial Cancer Hospital
        • Principal Investigator:
          • Jinming Yu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 to 75 years old (including boundary values)
  2. Volunteer to participate in this clinical study and sign informed consent;
  3. ECOG score 0-1;
  4. Expected survival ≥3 months;
  5. Patients diagnosed with esophageal squamous cell carcinoma by histological or cytological examination;
  6. Previously, only PD-1/PD-L1 Inhibitor Combined With Platinum-Based Chemotherapy were received;
  7. There is at least one measurable lesion that meets the RECIST 1.1 criteria;
  8. Adequate bone marrow and organ function.

Exclusion Criteria:

  1. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study
  2. Toxicities caused by previous anticancer therapy were not recovered to CTCAE 6.0 Grade≤1;
  3. Individuals with Leptomeningeal metastasis or Active brain metastases;
  4. Individuals with a history of GI perforation or fistula, unstable GI bleeding;
  5. Individuals with a history of severe cardiovascular and cerebrovascular diseases;
  6. The researcher determined that there are other situations that are not suitable for participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment group B: Paclitaxel, Docetaxel, Irinotecan.
Drug: Paclitaxel, Docetaxel, Irinotecan
Paclitaxel, Docetaxel, Irinotecan
Experimental: Treatment group A: FH-006
Drug: FH-006
FH-006

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Until death, assessed up to approximately 2 years
Measure description: Defined as time from randomization until the date of death due to any cause
Until death, assessed up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) by investigator assessment
Time Frame: Until progression or death, assessed up to approximately 1 year
Measure description: Defined as time from randomization until progression or death as assessed by the investigator
Until progression or death, assessed up to approximately 1 year
Objective response rate (ORR) by investigator assessment
Time Frame: Until progression, assessed up to approximately 1 year
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
Until progression, assessed up to approximately 1 year
Duration of response (DOR) by investigator assessment
Time Frame: Until progression or death, assessed up to approximately 1 year
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
Until progression or death, assessed up to approximately 1 year
Disease control rate (DCR) by investigator assessment
Time Frame: Until progression, assessed up to approximately 1 year
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
Until progression, assessed up to approximately 1 year
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Time Frame: until to 30 days after the last dose，assessed up to approximately 2 years
Measure description: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v6.0
until to 30 days after the last dose，assessed up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 10, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

August 25, 2026

First Submitted That Met QC Criteria

August 25, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FH-006-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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