Can a triple punch of immunotherapy and chemoradiation wipe out esophageal tumors before surgery?
NCT ID NCT07751055
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This trial is testing whether giving a combination of two immunotherapies (ipilimumab and sintilimab) along with chemotherapy and radiation before surgery can completely eliminate cancer cells in people with locally advanced esophageal cancer. About 44 adults with resectable esophageal squamous cell carcinoma will receive this pre-surgery regimen, followed by surgery to remove the tumor. The main goal is to see how many patients have no cancer cells left in the removed tissue, which could point to a more effective treatment strategy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of two immunotherapies (ipilimumab and sintilimab) plus chemotherapy and radiation given before surgery
- What this could lead to
- If successful, this approach could increase the chance of eliminating all cancer cells before surgery, potentially improving long-term outcomes for esophageal cancer patients.
- What could go wrong
- This is an early-phase trial with a small number of patients, so results may not be conclusive. Combining multiple treatments can increase side effects, and the approach may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 51 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. Treatment-naive patients without prior anti-tumor therapy. 3. Expected survival duration \> 6 months. 4. Aged between 18 and 75 years, either male or female. 5. Adequate function of major vital organs meeting the following laboratory criteria: 1. White blood cell (WBC) ≥4.0×10⁹/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; 2. Platelet count ≥100×10⁹/L; 3. Hemoglobin ≥9 g/dL; 4. Serum albumin ≥2.8 g/dL; 5. Total bilirubin ≤1.5 × ULN; ALT, AST and/or ALP ≤2.5 × ULN; 6. Serum creatinine ≤1.5 × ULN, or creatinine clearance \>60 mL/min. 6. Eastern Cooperative Oncology Group (ECOG) PS score: 0-1. 7. Capable of understanding the study protocol and signing written informed consent. 8. Absence of severe complications including active massive gastrointestinal hemorrhage, perforation, jaundice, bowel obstruction, or non-malignant fever \>38℃. 9. Female and male patients of childbearing potential must use effective contraception throughout relevant study period. 10. Good treatment compliance and availability for scheduled follow-up of efficacy and adverse events per study protocol. Exclusion Criteria: 1. Patients who have received prior anti-tumor therapies including chemotherapy, radiotherapy, surgery, immunotherapy, etc. 2. 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). 3. Patients with pre-existing hemorrhagic disorders. 4. Patients with unresectable disease due to other uncontrollable conditions. 5. Female patients who are pregnant or breastfeeding. 6. Patients lacking capacity to provide informed consent due to psychological, familial or social reasons. 7. Patients with peripheral neuropathy graded ≥ Grade 2 per CTCAE criteria. 8. 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. 9. Patients with more than 10 years of diabetes mellitus and poorly controlled blood glucose. 10. Patients with severe impairment of cardiac, pulmonary, hepatic or renal function, hematological diseases or cachexia that preclude tolerance to chemotherapy, radiotherapy or surgery. 11. 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. 12. Patients with prior history of interstitial lung disease or non-infectious pneumonia. 13. 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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No.651 Dongfeng East Road,Guangzhou
RECRUITINGGuangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Which Pre-Surgery combo extends life in esophageal cancer? a virtual trial seeks answers
- Can an AI eye guide surgeons to safer, faster cancer removal?
- Can early tumor response guide smarter cancer treatment?
- Could a smart combo of drugs and radiation help some esophageal cancer patients skip surgery?
- Could more surgery and radiation after immunotherapy keep esophageal cancer at bay?