NCT07711470Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 14 Jul 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07711470
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 140
- From 1 Jul 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.