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Can a triple punch of immunotherapy and chemoradiation wipe out esophageal tumors before surgery?

NCT ID NCT07751055

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 51 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • No.651 Dongfeng East Road,Guangzhou

    RECRUITING

    Guangzhou, Guangdong, China

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