A Phase 2 interventional study of Ipilimumab (1mg/kg) and Sinitilimab in Esophageal Squamous Cell Carcinoma (ESCC), sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
Among 32 studies in Esophageal Squamous Cell Carcinoma by Sun Yat-sen University — 13 open to participants now, 19 under way, 4 of them phase 3. Esophageal Squamous Cell Carcinoma · Sun Yat-sen University.
Among the 32 studies in Esophageal Squamous Cell Carcinoma by Sun Yat-sen University, this one is the 20th largest by planned enrollment of the 31 interventional ones that give a count, is one of 4 that started in 2026, is one of 21 in phase 2, reaches primary completion later than 9 of the 18 other live ones, and was the 32nd registered.
675 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 267 are open to participants now.
Browse Esophageal Squamous Cell Carcinoma studies →13 of the 32 studies in Esophageal Squamous Cell Carcinoma by Sun Yat-sen University are open now, in 1 country. Recruiting first, the newest first:
Sun Yat-sen University · Sites in China
Ages 18–75
Sun Yat-sen University · Sites in China
Ages 18–75
Sun Yat-sen University · Sites in China
Ages 18–80
Sun Yat-sen University · Sites in China
Ages 18–80
Sun Yat-sen University · Sites in China
By country, each count listing its studies:
Of the 180 Esophageal Squamous Cell Carcinoma studies recruiting now, 83 (46%) set no upper age limit and 76 (42%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 51 is below the median of 64 across 563 interventional studies indexed under Esophageal Squamous Cell Carcinoma.
Median enrollment 69 across the 31 interventional studies, 50 across the 1 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 618 are open to participants now.
2 of the studies in Esophageal Squamous Cell Carcinoma by Sun Yat-sen University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06187597Sun Yat-sen UniversityConsolidation of Toripalimab After Chemoradiotherapy in Elderly Esophageal Cancer (EC-CRT-007) | 2026-12-31 |
| NCT07751055Sun Yat-sen UniversityNeoadjuvant Chemoradiotherapy Combined With CTLA-4 Monoclonal Antibody Plus PD-1 Monoclonal Antibody for Locally Advanced Esophageal Cancer | 2027-04-01 |
Add all 2 to your calendar (.ics) → With an account.
Among the 32 studies in Esophageal Squamous Cell Carcinoma by Sun Yat-sen University, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate function of major vital organs meeting the following laboratory criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
neoadjuvant CTLA-4 monoclonal antibody combined with PD-1 monoclonal antibody plus preoperative chemoradiotherapy
Drug: Ipilimumab (1mg/kg) · Drug: Sinitilimab · Drug: Nab-paclitaxel + Cisplatin · Radiation: IMRT combine with cisplatin concurrent chemotherapy
Drug page: Ipilimumab
Chemotherapy and dual immunotherapy agents Anti-CTLA-4 monoclonal antibody (IBI310): 1 mg/kg via intravenous infusion on Day 1 (D1);
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.
Drug pages: Albumin-Bound Paclitaxel · Cisplatin
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.
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.
Pathologic complete response rate
No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes
Time frame: Two weeks after surgery
R0 resection rate
The persentage of patients who under complete resection
Time frame: Two weeks after surgery
Tumor Regression Grade
Time frame: Two weeks after surgery
Progression free survival
Progression free survival is defined as the time from randomization until objective tumor progression or death
Time frame: 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
Time frame: At the end of enrollment-up to 5 years in follow up
Incidence of perioperative complications
Incidence of complications
Time frame: Ninety days after surgery
Start is estimated for Aug 2026; primary completion for Apr 2027, 8 months later.
Of 153 non-industry phase 2 interventional studies under Esophageal Squamous Cell Carcinoma, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 55. This study's planned 8 months is below that.
Counting every sponsor, half of 173 studies reached it within 40 months; a quarter within 28 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Ipilimumab · Albumin-Bound Paclitaxel · Cisplatin
Esophageal Squamous Cell Carcinoma →