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Not Yet Recruiting NCT07790380

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.

Conditions: Locally Advanced, Recurrent or Metastatic ESCC Patients Who Have Failed Prior PD-1/PD-L1 Inhibitors Combined With Platinum-based Chemotherapy

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 480
Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Location: Shandong Provincial Cancer Hospital Jinan Shandong

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.

Eligibility 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07790380). StuddyBuddy aggregates publicly available trial information.