Esophageal Squamous Cell Carcinoma (ESCC)Phase 2SCOPENCT07711470
Phase II Study of Induction Chemoimmunotherapy Followed by Radiotherapy and Organ Preservation in Resectable ESCC
A Phase 2 study testing Sugemalimab and Chemotherapy, Nab-paclitaxel and Cisplatin in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- Sugemalimab and Chemotherapy, Nab-paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Jul 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
About this study
Official 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
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.
- Being tested
- Sugemalimab and Chemotherapy, Nab-paclitaxel, Cisplatin, Radiation Therapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugemalimab and ChemotherapyDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Major Response Organ Preservation Group | Experimental | Participants with a major clinical response after induction chemoimmunotherapy will receive radiotherapy plus sugemalimab followed by maintenance sugemalimab for organ preservation. Receives: Drug: Sugemalimab and Chemotherapy; Drug: Nab-paclitaxel; Drug: Cisplatin; Radiation: Radiation Therapy |
| Surgery Group | Active comparator | Participants with partial response or stable disease after induction therapy will undergo surgical resection. Receives: Drug: Sugemalimab and Chemotherapy; Drug: Nab-paclitaxel; Drug: Cisplatin |
| Radiotherapy Followed by Surgery Group | Active comparator | Participants with partial response or stable disease after induction therapy will receive radiotherapy followed by surgical resection. Receives: Drug: Sugemalimab and Chemotherapy; Drug: Nab-paclitaxel; Drug: Cisplatin; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year PFS rate
Measured: Up to 2 years after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell Carcinoma (ESCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711470
- Sponsor's protocol ID
- NCC6208
- Acronym
- SCOPE
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No