New drug may keep esophageal cancer from coming back after surgery
NCT ID NCT07332221
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug toripalimab, given after surgery, can help prevent esophageal cancer from returning in patients at high risk of recurrence. About 435 adults who have already had chemotherapy and immunotherapy before surgery will either receive toripalimab or be watched closely. The goal is to see if the drug improves survival and delays cancer return.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 435 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2031
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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. Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up. 2. Initial patients are those with resectable or potentially resectable (T1 N1-3 M0 or T2-3 N0-3 M0) thoracic segment esophageal squamous cell carcinoma (8th UICC-TNM staging); who have undergone surgical resection after 2 cycles of immunotherapy combined with chemotherapy and achieved R0 resection. 3. Age 18 to 75 years. 4. Preoperative examinations of various organ functions indicate no surgical contraindications. 5. The following laboratory tests confirm that bone marrow, liver, and kidney functions meet the study requirements: Hemoglobin ≥ 90 g/L; White blood cell count ≥ 4.0 × 10⁹/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); ALT and AST ≤ 2.5 times ULN; International normalized ratio (INR) of prothrombin time ≤ 1.5 times ULN, and activated partial thromboplastin time within the normal range; Creatinine ≤ 1.5 times ULN. 6. No postoperative chemotherapy, radiotherapy, or hormone therapy for malignant tumors has been administered; no history of other malignancies, excluding prostate cancer patients who have received hormone therapy and achieved disease-free survival (DFS) for over 5 years. 7. Physical status ECOG score 0 to 1. 8. Women of childbearing potential must agree to use contraceptive measures (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after study completion; serum or urine pregnancy test within 7 days before study enrollment must be negative, and patients must be non-lactating; men must agree to use contraceptive measures during the study and for 6 months after study completion. Exclusion Criteria: 1. Patients with double primary cancers; 2. Patients with infections requiring treatment; 3. Patients requiring continuous systemic corticosteroid therapy (Note: Replacement therapy (e.g., for thyroid insufficiency, insulin therapy, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic therapy and is permitted); 4. Patients with unstable angina within 3 months or myocardial infarction within 6 months; 5. Patients with psychiatric disorders; 6. Patients with existing or concurrent hemorrhagic disorders; 7. Female patients who are pregnant or breastfeeding; 8. Patients with bronchial asthma requiring intermittent use of bronchodilators or medical intervention; 9. Patients who have used immunosuppressive agents prior to enrollment due to comorbid conditions, with a dose equivalent to ≥10mg/day of oral prednisone sustained for more than 2 weeks; 10. Patients with abnormal coagulation function (PT \> 16s, APTT \> 53s, TT \> 21s, Fib \< 1.5g/L), bleeding tendency, or those receiving thrombolytic or anticoagulant therapy; 11. Patients with pre-existing or concurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe pulmonary impairment, etc.; 12. Patients with autoimmune diseases, immunodeficiency, or organ transplantation; 13. Patients with active Hepatitis B or Hepatitis C infection.
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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 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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Antibody-Drug conjugate targets advanced esophageal cancer after standard treatments fail
- Can a drug combo stop esophageal cancer from returning after surgery?
- Blood proteins may predict who beats esophageal cancer with chemoradiation
- Experimental drug put to the test against Hard-to-Treat GI cancers
- Can a drug combo shrink esophageal tumors before surgery?
- New Antibody-Drug conjugate put to the test against Hard-to-Treat cancers