FH-006 vs physician's choice chemotherapy for ESCC after PD-1/PD-L1 + platinum failure
Official title: 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.
Run by Jiangsu HengRui Medicine Co., Ltd. · NCT07790380 · Data updated 2026-11-12
This study tests whether FH-006 helps people with esophageal squamous cell carcinoma live longer than the physician’s choice second-line chemotherapy after prior PD-1/PD-L1 inhibitors with platinum have stopped working.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 480 (estimated) |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Drugs / interventions | Chemotherapy, immunotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | October 13, 2026 |
| Main results expected | June 30, 2029 |
| Study ends | June 30, 2029 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07790380 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 with histologically confirmed ESCC, measurable disease, ECOG 0–1, and progression after PD-1/PD-L1 inhibitor plus platinum therapy.
✕Probably not a fit
Patients with uncontrolled brain metastases, recent anti-tumor therapy, or severe organ dysfunction may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this phase 3 trial, adults with locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma who progressed after prior PD-1/PD-L1 inhibitor plus platinum therapy are randomized to receive FH-006 or the investigator-selected chemotherapy (paclitaxel, docetaxel, or irinotecan). Primary endpoint is overall survival; secondary endpoints may include response rate and progression-free survival. Eligibility requires good performance status, measurable disease, and adequate organ function, with no recent anti-cancer therapy and no active brain metastases. The trial is led by Jiangsu HengRui Medicine Co., Ltd., with the Shandong Provincial Cancer Hospital as the participating site.
Why it matters
Potential benefit: If FH-006 shows a survival advantage, patients could have a more effective second-line treatment option after PD-1/PD-L1 inhibitor failure.
How similar studies have gone: Prior studies in similar settings have explored alternative second-line regimens; the success of FH-006 in this exact context is not yet established and remains to be proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Shandong Provincial Cancer Hospital
Jinan, Shandong, China Recruiting
Study contacts
- Study coordinator: Shilong Yu
- Email: lin.ma.lm60@hengrui.com
- Phone: +86-021-23511999
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.