Locally Advanced, Recurrent or Metastatic ESCC Patients Who Have Failed Prior PD-1/PD-L1 Inhibitors Combined With Platinum-based Chemotherapy
Conditions
Brief 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.
Interventions
DRUGFH-006
FH-006
Paclitaxel, Docetaxel, Irinotecan
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) by investigator assessment | Until progression, assessed up to approximately 1 year | 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 |
| Duration of response (DOR) by investigator assessment | Until progression or death, assessed up to approximately 1 year | 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 |
| Disease control rate (DCR) by investigator assessment | Until progression, assessed up to approximately 1 year | 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 |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) | until to 30 days after the last dose，assessed up to approximately 2 years | Measure description: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v6.0 |
| Progression-free survival (PFS) by investigator assessment | Until progression or death, assessed up to approximately 1 year | Measure description: Defined as time from randomization until progression or death as assessed by the investigator |
Countries
China
Contacts
CONTACTShilong Yu
CONTACTLiang Hu
Outcome results
None listed