Interferon Gamma Plus Camrelizumab as Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Phase 2RecruitingNCT07787273

Hefei Cancer Hospital of the Chinese Academy of Sciences84 enrolled

Overview

This study aims to evaluate the efficacy and safety of interferon-gamma combined with camrelizumab plus chemotherapy as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma. Based on previous mechanistic research and preliminary clinical data, this trial intends to generate high-level evidence for this therapeutic strategy, which may improve the treatment landscape for patients with locally advanced esophageal squamous cell carcinoma.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Locally Advanced Esophageal Squamous Cell Carcinoma Neoadjuvant Therapy Camrelizumab

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged \>= 18 years; 2. Histologically confirmed esophageal squamous cell carcinoma (ESCC), clinical stage cT1b-3, N+, M0; 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 4. Expected overall survival \> 6 months; 5. Adequate bone marrow, hepatic, renal, coagulation, and thyroid function. Exclusion Criteria: 1. Active autoimmune disease; 2. Requirement for systemic immunosuppressive therapy; 3. Hypersensitivity to any study drug; 4. Uncontrolled significant organ disease (e.g., cardiac, pulmonary, hepatic, renal) or active infection; 5. Pregnant or lactating female.

Locations (2)

Hefei Cancer Hospital, Chinese Academy of Sciences

Hefei, Anhui, China

RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

Outcomes

Primary Outcomes

Pathological complete response rate

The proportion of patients achieving pathological complete response (absence of viable tumor cells in primary lesion and regional lymph nodes) evaluated by pathological examination of surgical specimens.

Time frame: At the time of surgical resection.

Secondary Outcomes

Objective Response Rate

The proportion of participants with confirmed complete response (CR) or partial response (PR) assessed per RECIST 1.1.

Time frame: At the end of Cycle 2, Cycle 4, (each cycle is 21 days).

Progression-free survival

Time from enrollment to disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.

Time frame: From date of enrollment until the date of first documented progression or death from any cause, whichever came first, assessed up to 24 months.

Overall Survival

Follow-up via outpatient visits or telephone interviews; defined as time from enrollment to death from any cause.

Time frame: From date of enrollment until death from any cause, assessed up to 24 months.

Duration of Response

Time from first observation of confirmed CR or PR to disease progression or death from any cause, assessed per RECIST Version 1.1.

Time frame: From the date of first documented confirmed response until disease progression or death from any cause, assessed up to 24 months.