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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07711470
- Acronym / sponsor ID
- SCOPE / NCC6208
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Major Response Organ Preservation Group | Experimental | Drug: Sugemalimab and Chemotherapy, Drug: Nab-paclitaxel, Drug: Cisplatin, Radiation: Radiation TherapyParticipants with a major clinical response after induction chemoimmunotherapy will receive radiotherapy plus sugemalimab followed by maintenance sugemalimab for organ preservation. |
| Surgery Group | Active comparator | Drug: Sugemalimab and Chemotherapy, Drug: Nab-paclitaxel, Drug: CisplatinParticipants with partial response or stable disease after induction therapy will undergo surgical resection. |
| Radiotherapy Followed by Surgery Group | Active comparator | Drug: Sugemalimab and Chemotherapy, Drug: Nab-paclitaxel, Drug: Cisplatin, Radiation: Radiation TherapyParticipants with partial response or stable disease after induction therapy will receive radiotherapy followed by surgical resection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugemalimab and ChemotherapySugemalimab 1200 mg administered intravenously every 3 weeks as induction, and maintenance immunotherapy. | Drug | Major Response Organ Preservation Group, Radiotherapy Followed by Surgery Group, Surgery Group |
| Nab-paclitaxel125 mg/m² administered intravenously on Days 1 and 8 every 3 weeks during induction therapy. | Drug | Major Response Organ Preservation Group, Radiotherapy Followed by Surgery Group, Surgery Group |
| Cisplatin75 mg/m² administered intravenously on Day 1 every 3 weeks during induction therapy. | Drug | Major Response Organ Preservation Group, Radiotherapy Followed by Surgery Group, Surgery Group |
| Radiation TherapyIMRT: PTV 41.4 Gy/23f，PGTV 49.45 Gy/23f | Radiation | Major Response Organ Preservation Group, Radiotherapy Followed by Surgery Group |
Primary outcome
2-year PFS rate
Time frame: Up to 2 years after initiation of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Esophageal Squamous Cell Carcinoma (ESCC)
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
Active, not recruiting
Clinical Application of an AI-based Dissection Trajectory Prediction System (ADTPS) in Endoscopic Submucosal Dissection
Esophageal Squamous Cell Carcinoma (ESCC), High-Grade Intraepithelial Neoplasia
RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors
NSCLC, NSCLC (Advanced Non-small Cell Lung Cancer)
RecruitingPhase 2
QL1706 Plus Celecoxib in Advanced Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year PFS rate (time frame: Up to 2 years after initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.