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