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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Overall Survival — Until death, assessed up to approximately 2 years Measure description: Defined as time from randomization until the date of death due to any cause
Trial sites (1)
Facility
City
Region
Status
Shandong Provincial Cancer Hospital
Jinan
Shandong
More Jiangsu HengRui Medicine Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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