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.
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.
1 other identifier
interventional
480
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2026
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2026
CompletedFirst Posted
Study publicly available on registry
August 27, 2026
CompletedStudy Start
First participant enrolled
October 10, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
Study Completion
Last participant's last visit for all outcomes
June 30, 2029
August 27, 2026
August 1, 2026
2.7 years
August 25, 2026
August 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
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 Outcomes (5)
Progression-free survival (PFS) by investigator assessment
Until progression or death, assessed up to approximately 1 year
Objective response rate (ORR) by investigator assessment
Until progression, assessed up to approximately 1 year
Duration of response (DOR) by investigator assessment
Until progression or death, assessed up to approximately 1 year
Disease control rate (DCR) by investigator assessment
Until progression, assessed up to approximately 1 year
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
until to 30 days after the last dose，assessed up to approximately 2 years
Study Arms (2)
Treatment group A: FH-006
EXPERIMENTALTreatment group B: Paclitaxel, Docetaxel, Irinotecan.
ACTIVE COMPARATORInterventions
Paclitaxel, Docetaxel, Irinotecan
Eligibility Criteria
You may qualify if:
- 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;
- Patients diagnosed with esophageal squamous cell carcinoma by histological or cytological examination;
- Previously, only PD-1/PD-L1 Inhibitor Combined With Platinum-Based Chemotherapy were received;
- There is at least one measurable lesion that meets the RECIST 1.1 criteria;
- Adequate bone marrow and organ function.
You may not qualify if:
- 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;
- Individuals with a history of severe cardiovascular and cerebrovascular diseases;
- The researcher determined that there are other situations that are not suitable for participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shandong Provincial Cancer Hospital
Jinan, Shandong, 250117, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2026
First Posted
August 27, 2026
Study Start (Estimated)
October 10, 2026
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
June 30, 2029
Last Updated
August 27, 2026
Record last verified: 2026-08