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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07711470

Acronym

SCOPE

Enrollment

140

Registered

2026-07-17

Start date

2026-07-01

Completion date

2029-07-31

Last updated

2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Brief summary

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.

Interventions

DRUGSugemalimab and Chemotherapy

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

DRUGNab-paclitaxel

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

DRUGCisplatin

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

RADIATIONRadiation Therapy

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
2-year PFS rate	Up to 2 years after initiation of treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026