Clinical trial · Interventional
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.
NCT07790380CI-TRIAL-00124112not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced, Recurrent or Metastatic ESCC Patients Who Have Failed Prior PD-1/PD-L1 Inhibitors Combined With Platinum-based Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FH-006 | Drug | — | UNRESOLVED |
| Paclitaxel, Docetaxel, Irinotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group A: FH-006
- interventionNames
- Drug: FH-006
- type
- ACTIVE_COMPARATOR
- label
- Treatment group B: Paclitaxel, Docetaxel, Irinotecan.
- interventionNames
- Drug: Paclitaxel, Docetaxel, Irinotecan
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Until death, assessed up to approximately 2 years
- description
- Measure description: Defined as time from randomization until the date of death due to any cause
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.