Esophageal Squamous Cell Carcinoma (ESCC)Phase 2NEOCRTE2601NCT07751055
Neoadjuvant Chemoradiotherapy Combined With CTLA-4 Monoclonal Antibody Plus PD-1 Monoclonal Antibody for Locally Advanced Esophageal Cancer
A Phase 2 study testing Ipilimumab (1mg/kg), Sinitilimab and Nab-paclitaxel + Cisplatin in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective, single-arm phase II clinical trial intended to investigate the efficacy of neoadjuvant CTLA-4 monoclonal antibody combined with PD-1 monoclonal antibody plus preoperative chemoradiotherapy for locally advanced esophageal cancer. 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?
- Ipilimumab (1mg/kg), Sinitilimab and Nab-paclitaxel + Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Dec 2030
- 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
- Histologically confirmed resectable thoracic esophageal squamous cell carcinoma (ESCC); pretreatment clinical stage of T1-4aN1-3M0 or T3-4aN0M0 per the 8th edition of UICC staging system.
- Treatment-naive patients without prior anti-tumor therapy.
- Expected survival duration > 6 months.
- Aged between 18 and 75 years, either male or female.
- Adequate function of major vital organs meeting the following laboratory criteria:
- White blood cell (WBC) ≥4.0×10⁹/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L;
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- Platelet count ≥100×10⁹/L;
- Hemoglobin ≥9 g/dL;
- Serum albumin ≥2.8 g/dL;
- Total bilirubin ≤1.5 × ULN; ALT, AST and/or ALP ≤2.5 × ULN;
- Serum creatinine ≤1.5 × ULN, or creatinine clearance >60 mL/min.
- Eastern Cooperative Oncology Group (ECOG) PS score: 0-1.
- Capable of understanding the study protocol and signing written informed consent.
- Absence of severe complications including active massive gastrointestinal hemorrhage, perforation, jaundice, bowel obstruction, or non-malignant fever >38℃.
- Female and male patients of childbearing potential must use effective contraception throughout relevant study period.
- Good treatment compliance and availability for scheduled follow-up of efficacy and adverse events per study protocol.
Who cannot join
- Patients who have received prior anti-tumor therapies including chemotherapy, radiotherapy, surgery, immunotherapy, etc.
- Patients with known or suspected hypersensitivity to any components of CTLA-4 inhibitors, sintilimab or other monoclonal antibodies, as well as chemotherapeutic agents (nab-paclitaxel and cisplatin).
- Patients with pre-existing hemorrhagic disorders.
- Patients with unresectable disease due to other uncontrollable conditions.
- Female patients who are pregnant or breastfeeding.
- Patients lacking capacity to provide informed consent due to psychological, familial or social reasons.
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- Patients with peripheral neuropathy graded ≥ Grade 2 per CTCAE criteria.
- Patients with a prior history of other malignancies besides esophageal cancer, except for non-melanoma skin cancer, cervical carcinoma in situ, or previously cured early-stage prostate cancer.
- Patients with more than 10 years of diabetes mellitus and poorly controlled blood glucose.
- Patients with severe impairment of cardiac, pulmonary, hepatic or renal function, hematological diseases or cachexia that preclude tolerance to chemotherapy, radiotherapy or surgery.
- Patients with active or past history of autoimmune diseases (including but not limited to colitis, hepatitis, hyperthyroidism), or history of immunodeficiency diseases (HIV positive, other acquired or congenital immunodeficiency disorders), or previous history of solid organ or allogeneic hematopoietic stem cell transplantation.
- Patients with prior history of interstitial lung disease or non-infectious pneumonia.
- Subjects with active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or active hepatitis C (HCV antibody positive with HCV-RNA above the lower limit of quantification of the assay).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
No.651 Dongfeng East Road,Guangzhou
Guangzhou, Guangdong
Hong Yang Chief Physician, 86-13560405144, yanghong@sysucc.org.cn
About this study
Official title: A Prospective, Single-Arm Phase II Clinical Study of Neoadjuvant Chemoradiotherapy Combined With CTLA-4 Monoclonal Antibody Plus PD-1 Monoclonal Antibody for Locally Advanced Esophageal Cancer
This is a prospective, single-arm phase II clinical trial intended to investigate the efficacy of neoadjuvant CTLA-4 monoclonal antibody combined with PD-1 monoclonal antibody plus preoperative chemoradiotherapy for locally advanced esophageal cancer. A total of 44 patients with resectable esophageal squamous cell carcinoma (ESCC) will be enrolled.All enrolled subjects will receive induction therapy with the combination of a CTLA-4 inhibitor and a PD-1 inhibitor. Three weeks afterwards, patients will transition to concurrent chemoradiotherapy combined with PD-1 inhibitor. Intensity-modulated radiotherapy (IMRT) will be delivered at a total dose of 40 Gy in 20 fractions. Radical esophagectomy with two-field thoracic and abdominal lymph node dissection will be performed 6-8 weeks after completion of chemoradiotherapy.The primary objective of this trial is to evaluate the efficacy and safety of the triplet regimen consisting of CTLA-4 inhibitor plus PD-1 inhibitor combined with preoperative chemoradiotherapy in locally advanced esophageal cancer, so as to further optimize the multimodal therapeutic strategy for esophageal cancer.
Read the detailed description
This is a single-arm, phase II, single-center clinical trial enrolling patients with resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC) staged as T1-4aN1-3M0 or T3-4aN0M0 per the 8th edition of the UICC TNM staging system. A total of 51 subjects are planned for enrollment. Patients will receive neoadjuvant concurrent chemoradiotherapy combined with dual immune checkpoint blockade (anti-CTLA-4 plus anti-PD-1 monoclonal antibodies) to evaluate the efficacy and safety of this regimen.
Treatment Regimens Chemotherapy and dual immunotherapy agents Anti-CTLA-4 monoclonal antibody (IBI310): 1 mg/kg via intravenous infusion on Day 1 (D1);Anti-PD-1 monoclonal antibody (sintilimab): 200 mg per administration via intravenous infusion on D1, D22 and D43;Nab-paclitaxel: 75 mg/m² via intravenous infusion on D22, D29, D36 and D43;Cisplatin: 25 mg/m² via intravenous infusion on D22, D29, D36 and D43.
Radiotherapy Intensity-modulated radiotherapy (IMRT) is delivered at a total dose of 40 Gy in 20 fractions (40 Gy/20 f), initiated on D22 with 5 fractions per week to be completed within 4 weeks.
Surgery Preoperative re-evaluation is scheduled at 6-8 weeks after completion of neoadjuvant chemoradiotherapy plus dual immunotherapy. Patients without surgical contraindications will undergo radical esophagectomy plus two-field (thoracoabdominal) lymph node dissection.
- Being tested
- Ipilimumab (1mg/kg), Sinitilimab, Nab-paclitaxel + Cisplatin, IMRT combine with cisplatin concurrent chemotherapy
- Keywords
- chemotherapy, neoadjuvant, immune checkpoint inhibitor, locally advanced, CTLA-4 monoclonal antibody
- 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.
Ipilimumab (1mg/kg)Drug
Chemotherapy and dual immunotherapy agents Anti-CTLA-4 monoclonal antibody (IBI310): 1 mg/kg via intravenous infusion on Day 1 (D1);
SinitilimabDrug
Sintilimab (anti-PD-1 monoclonal antibody) will be administered at a dose of 200 mg via intravenous infusion on Day 1, Day 22 and Day 43.
Nab-paclitaxel + CisplatinDrug
Nab-paclitaxel: 75 mg/m² via intravenous infusion on D22, D29, D36 and D43; Cisplatin: 25 mg/m² via intravenous infusion on D22, D29, D36 and D43.
IMRT combine with cisplatin concurrent chemotherapyRadiation
Intensity-modulated radiotherapy (IMRT) will be adopted with a total dose of 40 Gy in 20 fractions. Radiotherapy starts on Day 22, administered 5 times per week and completed within 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm | Experimental | neoadjuvant CTLA-4 monoclonal antibody combined with PD-1 monoclonal antibody plus preoperative chemoradiotherapy Receives: Drug: Ipilimumab (1mg/kg); Drug: Sinitilimab; Drug: Nab-paclitaxel + Cisplatin; Radiation: IMRT combine with cisplatin concurrent chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response rate
No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes
Measured: Two weeks after surgery
Secondary outcomes (5)
R0 resection rate
The persentage of patients who under complete resection
Measured: Two weeks after surgery
Tumor Regression Grade
Measured: Two weeks after surgery
Progression free survival
Progression free survival is defined as the time from randomization until objective tumor progression or death
Measured: At end of enrollment-up to 5 years in follow up
Overall survival
Overall survival will be calculated from the date of randomization and an event registered on the date of death from those with no death recorded on the day the database is frozen,will be censored on the date of last follow up
Measured: At the end of enrollment-up to 5 years in follow up
Incidence of perioperative complications
Incidence of complications
Measured: Ninety days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion31 Dec 2030 (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 Sun Yat-sen UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Hong, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751055
- Sponsor's protocol ID
- SL-B2026-477-02
- Acronym
- NEOCRTE2601
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm Phase II Clinical Study of Neoadjuvant Chemoradiotherapy Combined With CTLA-4 Monoclonal Antibody Plus PD-1 Monoclonal Antibody for Locally Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT07751055
- Acronym / sponsor ID
- NEOCRTE2601 / SL-B2026-477-02
- Keywords
- chemotherapy, neoadjuvant, immune checkpoint inhibitor, locally advanced, CTLA-4 monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 7 Aug 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 is a prospective, single-arm phase II clinical trial intended to investigate the efficacy of neoadjuvant CTLA-4 monoclonal antibody combined with PD-1 monoclonal antibody plus preoperative chemoradiotherapy for locally advanced esophageal cancer. A total of 44 patients with resectable esophageal squamous cell carcinoma (ESCC) will be enrolled.All enrolled subjects will receive induction therapy with the combination of a CTLA-4 inhibitor and a PD-1 inhibitor. Three weeks afterwards, patients will transition to concurrent chemoradiotherapy combined with PD-1 inhibitor. Intensity-modulated radiotherapy (IMRT) will be delivered at a total dose of 40 Gy in 20 fractions. Radical esophagectomy with two-field thoracic and abdominal lymph node dissection will be performed 6-8 weeks after completion of chemoradiotherapy.The primary objective of this trial is to evaluate the efficacy and safety of the triplet regimen consisting of CTLA-4 inhibitor plus PD-1 inhibitor combined with preoperative chemoradiotherapy in locally advanced esophageal cancer, so as to further optimize the multimodal therapeutic strategy for esophageal cancer.
Detailed description
This is a single-arm, phase II, single-center clinical trial enrolling patients with resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC) staged as T1-4aN1-3M0 or T3-4aN0M0 per the 8th edition of the UICC TNM staging system. A total of 51 subjects are planned for enrollment. Patients will receive neoadjuvant concurrent chemoradiotherapy combined with dual immune checkpoint blockade (anti-CTLA-4 plus anti-PD-1 monoclonal antibodies) to evaluate the efficacy and safety of this regimen.
Treatment Regimens Chemotherapy and dual immunotherapy agents Anti-CTLA-4 monoclonal antibody (IBI310): 1 mg/kg via intravenous infusion on Day 1 (D1);Anti-PD-1 monoclonal antibody (sintilimab): 200 mg per administration via intravenous infusion on D1, D22 and D43;Nab-paclitaxel: 75 mg/m² via intravenous infusion on D22, D29, D36 and D43;Cisplatin: 25 mg/m² via intravenous infusion on D22, D29, D36 and D43.
Radiotherapy Intensity-modulated radiotherapy (IMRT) is delivered at a total dose of 40 Gy in 20 fractions (40 Gy/20 f), initiated on D22 with 5 fractions per week to be completed within 4 weeks.
Surgery Preoperative re-evaluation is scheduled at 6-8 weeks after completion of neoadjuvant chemoradiotherapy plus dual immunotherapy. Patients without surgical contraindications will undergo radical esophagectomy plus two-field (thoracoabdominal) lymph node dissection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm | Experimental | Drug: Ipilimumab (1mg/kg), Drug: Sinitilimab, Drug: Nab-paclitaxel + Cisplatin, Radiation: IMRT combine with cisplatin concurrent chemotherapyneoadjuvant CTLA-4 monoclonal antibody combined with PD-1 monoclonal antibody plus preoperative chemoradiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed resectable thoracic esophageal squamous cell carcinoma (ESCC); pretreatment clinical stage of T1-4aN1-3M0 or T3-4aN0M0 per the 8th edition of UICC staging system.
- Treatment-naive patients without prior anti-tumor therapy.
- Expected survival duration > 6 months.
- Aged between 18 and 75 years, either male or female.
- Adequate function of major vital organs meeting the following laboratory criteria:
Key exclusion criteria (13 listed)
- Patients who have received prior anti-tumor therapies including chemotherapy, radiotherapy, surgery, immunotherapy, etc.
- Patients with known or suspected hypersensitivity to any components of CTLA-4 inhibitors, sintilimab or other monoclonal antibodies, as well as chemotherapeutic agents (nab-paclitaxel and cisplatin).
- Patients with pre-existing hemorrhagic disorders.
- Patients with unresectable disease due to other uncontrollable conditions.
- Female patients who are pregnant or breastfeeding.
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 |
|---|---|---|
| Ipilimumab (1mg/kg)Chemotherapy and dual immunotherapy agents Anti-CTLA-4 monoclonal antibody (IBI310): 1 mg/kg via intravenous infusion on Day 1 (D1); | Drug | Single-Arm |
| SinitilimabSintilimab (anti-PD-1 monoclonal antibody) will be administered at a dose of 200 mg via intravenous infusion on Day 1, Day 22 and Day 43. | Drug | Single-Arm |
| Nab-paclitaxel + CisplatinNab-paclitaxel: 75 mg/m² via intravenous infusion on D22, D29, D36 and D43; Cisplatin: 25 mg/m² via intravenous infusion on D22, D29, D36 and D43. | Drug | Single-Arm |
| IMRT combine with cisplatin concurrent chemotherapyIntensity-modulated radiotherapy (IMRT) will be adopted with a total dose of 40 Gy in 20 fractions. Radiotherapy starts on Day 22, administered 5 times per week and completed within 4 weeks. | Radiation | Single-Arm |
Primary outcome
Pathologic complete response rate
Time frame: Two weeks after surgery
No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes
5 secondary outcomes
R0 resection rate
Time frame: Two weeks after surgery
Tumor Regression Grade
Time frame: Two weeks after surgery
Progression free survival
Time frame: At end of enrollment-up to 5 years in follow up
Overall survival
Time frame: At the end of enrollment-up to 5 years in follow up
Incidence of perioperative complications
Time frame: Ninety days after surgery
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 7 Aug 2026.
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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.
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 Ipilimumab (1mg/kg), Sinitilimab and Nab-paclitaxel + Cisplatin in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Sun Yat-sen University 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 16 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 7 Aug 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?
Contact Hong Yang (86-135560405144, yanghong@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response rate (time frame: Two weeks after surgery). 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 7 Aug 2026.