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.

Phase 3Not Yet RecruitingNCT07790380

Jiangsu HengRui Medicine Co., Ltd.480 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

480

Conditions

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

Interventions

FH-006

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Overall Survival

Measure description: Defined as time from randomization until the date of death due to any cause

Time frame: Until death, assessed up to approximately 2 years

Secondary Outcomes

Progression-free survival (PFS) by investigator assessment

Measure description: Defined as time from randomization until progression or death as assessed by the investigator

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: until to 30 days after the last dose，assessed up to approximately 2 years