Phase II Study of Induction Chemoimmunotherapy Followed by Radiotherapy and Organ Preservation in Resectable ESCC

Phase 2Active Not RecruitingNCT07711470

Cancer Institute and Hospital, Chinese Academy of Medical Sciences140 enrolled

Overview

This multicenter, prospective Phase II study investigates a response-adapted organ-preservation strategy in patients with resectable esophageal squamous cell carcinoma (ESCC). Participants will receive two cycles of induction chemoimmunotherapy with sugemalimab, nab-paclitaxel, and cisplatin. Patients who achieve a major clinical response will receive definitive radiotherapy plus sugemalimab followed by maintenance sugemalimab, while non-major responders will undergo surgery-based treatment strategies. The study aims to evaluate the efficacy and safety of this tailored treatment approach, with the primary endpoint being 2-year progression-free survival. Secondary and exploratory objectives include survival outcomes, quality of life, nutritional status.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

Sugemalimab 1200 mg administered intravenously every 3 weeks as induction, and maintenance immunotherapy.

Nab-paclitaxelDRUG

125 mg/m² administered intravenously on Days 1 and 8 every 3 weeks during induction therapy.

CisplatinDRUG

75 mg/m² administered intravenously on Day 1 every 3 weeks during induction therapy.

Radiation TherapyRADIATION

IMRT: PTV 41.4 Gy/23f，PGTV 49.45 Gy/23f

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: Age 18-75 years. Histologically confirmed, previously untreated resectable esophageal squamous cell carcinoma (ESCC). Clinical stage IB-III according to AJCC 8th edition. ECOG performance status 0-1. Adequate hematologic, hepatic, and renal function. Ability to provide written informed consent. Exclusion Criteria: Prior systemic therapy, radiotherapy, surgery, or immunotherapy for ESCC. Distant metastases or suspicious cervical lymph node metastases. Prior treatment with PD-1 or PD-L1 inhibitors. Active autoimmune disease requiring systemic treatment. Uncontrolled infection, including active hepatitis or HIV infection. Significant cardiovascular, pulmonary, or other serious medical conditions that may interfere with study participation.

Locations (1)

National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Outcomes

Primary Outcomes

2-year PFS rate

Time frame: Up to 2 years after initiation of treatment

Data from ClinicalTrials.gov

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