Esophageal CancerPhase 3NCT07332221
Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter Clinical Trial
A Phase 3 study testing Toripalimab monotherapy in people with Esophageal Cancer, run by Henan Cancer Hospital.
Trial summary
This study is a prospective, multicenter, multi-cohort Phase III clinical trial. It primarily enrolls high-risk recurrent esophageal cancer patients who have undergone R0 resection after neoadjuvant chemoimmunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Toripalimab monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 1 Oct 2031
- Phase
- Phase 3
- 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
- Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.
- 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.
- Age 18 to 75 years.
- Preoperative examinations of various organ functions indicate no surgical contraindications.
- 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.
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- 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.
- Physical status ECOG score 0 to 1.
- 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.
Who cannot join
- Patients with double primary cancers;
- Patients with infections requiring treatment;
- 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);
- Patients with unstable angina within 3 months or myocardial infarction within 6 months;
- Patients with psychiatric disorders;
- Patients with existing or concurrent hemorrhagic disorders;
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- Female patients who are pregnant or breastfeeding;
- Patients with bronchial asthma requiring intermittent use of bronchodilators or medical intervention;
- 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;
- Patients with abnormal coagulation function (PT > 16s, APTT > 53s, TT > 21s, Fib < 1.5g/L), bleeding tendency, or those receiving thrombolytic or anticoagulant therapy;
- Patients with pre-existing or concurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe pulmonary impairment, etc.;
- Patients with autoimmune diseases, immunodeficiency, or organ transplantation;
- Patients with active Hepatitis B or Hepatitis C infection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter, Phase III Clinical Trial
This study is a prospective, multicenter, multi-cohort Phase III clinical trial. It primarily enrolls high-risk recurrent esophageal cancer patients who have undergone R0 resection after neoadjuvant chemoimmunotherapy. Eligible patients are stratified based on pathological lymph node status and receive either toripalimab monotherapy as maintenance treatment or clinical observation only.
Read the detailed description
This is a prospective, multicenter, multi-cohort Phase III clinical study. It primarily enrolls high-risk recurrent esophageal cancer patients who have achieved R0 resection after undergoing neoadjuvant chemoimmunotherapy. Eligible patients are stratified into two cohorts based on pathological lymph node status: Cohort A (ypN+ cohort) and Cohort B (ypN0 cohort).
Interventions and Treatment Schedule Cohort A (ypN+ cohort): Patients receive toripalimab monotherapy as consolidation/maintenance treatment.
Dosage: Toripalimab 240 mg. Administration: Every 3 weeks per cycle. Duration: Up to 17 cycles, with a total treatment period not exceeding one year.
Cohort B (ypN0 cohort): Patients are randomized 1:1 into two groups:
Experimental Group: Receives toripalimab monotherapy as consolidation/maintenance treatment (same dosage and schedule as Cohort A).
Control Group: Undergoes postoperative observation only. Follow-up and Assessments Disease Evaluation: Assessments including chest + upper abdominal contrast-enhanced CT + neck contrast-enhanced CT are performed every 3 months for 2 years, then every 6 months until the 5th year. PET-CT, chest MRI, gastroscopy, and bronchoscopy are conducted when necessary.
Safety Monitoring: Adverse events (AEs) are monitored throughout the study and graded according to CTCAE v5.0. Safety follow-up is performed for all subjects who received the study treatment, including those who discontinued early.
- Conditions
- Esophageal Cancer
- Being tested
- Toripalimab monotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab monotherapyDrug
Toripalimab monotherapy as maintenance treatment
| Study group | Role | What they receive |
|---|---|---|
| ypN+，receive toripalimab monotherapy as maintenance treatment | Experimental | R0 resection for esophageal cancer, ypN+ Receives: Drug: Toripalimab monotherapy |
| ypN-，receive toripalimab monotherapy as maintenance treatment | Experimental | R0 resection for esophageal cancer, ypN-，receive toripalimab monotherapy as maintenance treatment Receives: Drug: Toripalimab monotherapy |
| ypN-，clinical observation only | No intervention | R0 resection for esophageal cancer, ypN-，no further treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year OS
the percentage of patients in a study who are still alive after 2years
Measured: every 3 months for 2 years
Secondary outcomes (2)
DFS
DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death for any reason
Measured: every 6 months until the 5th year
OS
OS (Overall Survival) is defined as the time from randomization (or treatment initiation) to death from any cause.
Measured: every 6 months until the 5th year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 435 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, YanZheng,MD, Henan Cancer Hospital
- Investigators
- Yan Zheng, M.D., Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332221
- Sponsor's protocol ID
- 2025-586
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter, Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT07332221
- Acronym / sponsor ID
- 2025-586
- Conditions
- Esophageal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 435 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 12 Jan 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 study is a prospective, multicenter, multi-cohort Phase III clinical trial. It primarily enrolls high-risk recurrent esophageal cancer patients who have undergone R0 resection after neoadjuvant chemoimmunotherapy. Eligible patients are stratified based on pathological lymph node status and receive either toripalimab monotherapy as maintenance treatment or clinical observation only.
Detailed description
This is a prospective, multicenter, multi-cohort Phase III clinical study. It primarily enrolls high-risk recurrent esophageal cancer patients who have achieved R0 resection after undergoing neoadjuvant chemoimmunotherapy. Eligible patients are stratified into two cohorts based on pathological lymph node status: Cohort A (ypN+ cohort) and Cohort B (ypN0 cohort).
Interventions and Treatment Schedule Cohort A (ypN+ cohort): Patients receive toripalimab monotherapy as consolidation/maintenance treatment.
Dosage: Toripalimab 240 mg. Administration: Every 3 weeks per cycle. Duration: Up to 17 cycles, with a total treatment period not exceeding one year.
Cohort B (ypN0 cohort): Patients are randomized 1:1 into two groups:
Experimental Group: Receives toripalimab monotherapy as consolidation/maintenance treatment (same dosage and schedule as Cohort A).
Control Group: Undergoes postoperative observation only. Follow-up and Assessments Disease Evaluation: Assessments including chest + upper abdominal contrast-enhanced CT + neck contrast-enhanced CT are performed every 3 months for 2 years, then every 6 months until the 5th year. PET-CT, chest MRI, gastroscopy, and bronchoscopy are conducted when necessary.
Safety Monitoring: Adverse events (AEs) are monitored throughout the study and graded according to CTCAE v5.0. Safety follow-up is performed for all subjects who received the study treatment, including those who discontinued early.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ypN+，receive toripalimab monotherapy as maintenance treatment | Experimental | Drug: Toripalimab monotherapyR0 resection for esophageal cancer, ypN+ |
| ypN-，receive toripalimab monotherapy as maintenance treatment | Experimental | Drug: Toripalimab monotherapyR0 resection for esophageal cancer, ypN-，receive toripalimab monotherapy as maintenance treatment |
| ypN-，clinical observation only | No intervention | –R0 resection for esophageal cancer, ypN-，no further treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.
- 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.
- Age 18 to 75 years.
- Preoperative examinations of various organ functions indicate no surgical contraindications.
- The following laboratory tests confirm that bone marrow, liver, and kidney functions meet the study requirements:
Key exclusion criteria (13 listed)
- Patients with double primary cancers;
- Patients with infections requiring treatment;
- 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);
- Patients with unstable angina within 3 months or myocardial infarction within 6 months;
- Patients with psychiatric disorders;
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 |
|---|---|---|
| Toripalimab monotherapyToripalimab monotherapy as maintenance treatment | Drug | ypN+，receive toripalimab monotherapy as maintenance treatment, ypN-，receive toripalimab monotherapy as maintenance treatment |
Primary outcome
2-year OS
Time frame: every 3 months for 2 years
the percentage of patients in a study who are still alive after 2years
2 secondary outcomes
DFS
Time frame: every 6 months until the 5th year
OS
Time frame: every 6 months until the 5th year
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 12 Jan 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.
Yan Zheng, M.D. principal investigator
Henan Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toripalimab monotherapy in people with Esophageal Cancer, run by Henan Cancer Hospital.
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 9 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: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yan Zheng, M.D. (0371-65587610, hnszlyylixiang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year OS (time frame: every 3 months for 2 years). 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 12 Jan 2026.