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NCT Number: NCT07711470

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Esophageal Squamous Cell Carcinoma (ESCC) Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sugemalimab and Chemotherapy

Drug

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

Nab-paclitaxel

Drug

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

Cisplatin

Drug

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

radiation therapy

Radiation

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

Primary outcomes

  1. 2-year PFS rate

    Time frame: Up to 2 years after initiation of treatment

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

A Multicenter, Prospective Phase II Trial Evaluating Induction Chemotherapy Plus Sugemalimab Followed by Sequential Radiotherapy and Response-Guided Surgery or Organ Preservation in Resectable Esophageal Squamous Cell Carcinoma

Acronym: SCOPE

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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