Locally Advanced, Recurrent or Metastatic ESCC Patients Who Have Failed Prior PD-1/PD-L1 Inhibitors Combined With Platinum-based ChemotherapyPhase 3NCT07790380

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 Phase 3 study testing FH-006 and Paclitaxel, Docetaxel, Irinotecan in people with Locally Advanced, Recurrent or Metastatic ESCC Patients Who Have Failed Prior PD-1/PD-L1 Inhibitors Combined With Platinum-based Chemotherapy, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Locally Advanced, Recurrent or Metastatic ESCC Patients Who Have Failed Prior PD-1/PD-L1 Inhibitors Combined With Platinum-based Chemotherapy
What is being tested?: FH-006 and Paclitaxel, Docetaxel, Irinotecan
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 480 participants
Where: 1 siteChina
Study dates: 10 Oct 2026to 30 Jun 2029
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shilong Yu contact

+86-021-23511999

lin.ma.lm60@hengrui.com

Liang Hu contact

18036618148

Liang.hu@hengrui.com

China1 site

Shandong Provincial Cancer Hospital
Jinan, Shandong, 250117
Jinming Yu

Other trials in China

About this study

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.

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: Locally Advanced, Recurrent or Metastatic ESCC Patients Who Have Failed Prior PD-1/PD-L1 Inhibitors Combined With Platinum-based Chemotherapy
Being tested: FH-006, Paclitaxel, Docetaxel, Irinotecan
Medical subject headings: Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FH-006Drug
FH-006
Paclitaxel, Docetaxel, IrinotecanDrug
Paclitaxel, Docetaxel, Irinotecan

Study groups in NCT07790380
Study group	Role	What they receive
Treatment group A: FH-006	Experimental	Not described Receives: Drug: FH-006
Treatment group B: Paclitaxel, Docetaxel, Irinotecan.	Active comparator	Not described Receives: Drug: Paclitaxel, Docetaxel, Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 202630 Jun 2029

First posted27 Aug 2026
Study start10 Oct 2026 (estimated)
Primary completion30 Jun 2029 (estimated)
Study completion30 Jun 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Locally Advanced, Recurrent or Metastatic ESCC Patients Who Have Failed Prior PD-1/PD-L1 Inhibitors Combined With Platinum-based ChemotherapyStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 480 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07790380
Sponsor's protocol ID: FH-006-301
Status last verified: Aug 2026
First submitted: 25 Aug 2026
Last updated: 27 Aug 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided