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AzTrials

Esophageal Squamous Cell Carcinoma (ESCC)Phase 3NCT07246330

Stratified Treatment in Unresectable Locally Advanced ESCC Without Progression After Chemoimmunotherapy Induction Plus CCRT: Toripalimab Consolidation vs observation--a Prospective, Randomized, Controlled Phase III Multicenter Study

A Phase 3 study testing Toripalimab in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a prospective, randomized controlled, phase III multicenter trial. Its objectives are to explore the stratified application of consolidation immunotherapy after chemoimmunotherapy induction plus concurrent chemoradiotherapy, identify the potential beneficiary population of consolidation immunotherapy… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
1 siteChina
Study dates
23 Mar 2026to 15 Dec 2029
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, signed informed consent, good compliance with follow-up;
  • Aged 18-75 years (inclusive), male or female;
  • Clinically staged II-IVa unresectable (AJCC 8th ed.: cT1N2-3M0/cT2-4bN0-3M0) or IVb (supraclavicular lymph node metastasis only); the patient had no disease progression after 2-4 cycles of chemo-immunotherapy induction combined with concurrent chemoradiotherapy (CCRT). Patients receiving CCRT must meet the following criteria: Patients with inoperable tumors must have received at least 2 cycles of weekly regimen or 1 cycle of 3-week platinum-based chemotherapy combined with radical radiotherapy (50-64 Gy) and have no evidence of radiographic disease progression (according to RECISTv1.1) as compared to before and after radical concurrent chemoradiation;
  • ECOG PS 0-1;
  • Expected survival ≥3 months;
  • Fresh or archived tumor tissue samples within 6 months should be provided for biomarker analysis. The sample type is FFPE tumor tissue block or at least 10 unstained FFPE tumor tissue sections with a thickness of 3-5 μm. For patients who cannot provide tissue samples meeting the above requirements, the investigator should discuss and determine whether to enroll;
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  • Adequate organ and bone marrow function defined as:
  • ANC ≥1.5×10⁹/L;
  • Platelets ≥100×10⁹/L;
  • Hemoglobin ≥9g/dL;
  • Serum albumin ≥2.8g/dL;
  • Total bilirubin ≤1.5×ULN; ALT/AST/AKP ≤2.5×ULN;
  • Serum creatinine ≤1.5×ULN or creatinine clearance ≥60mL/min (Cockcroft-Gault);
  • International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN [Patients receiving stable-dose anticoagulant therapy (e.g., low-molecular-weight heparin or warfarin) with an INR within the expected therapeutic range of the anticoagulant are eligible];
  • Females of childbearing potential: negative pregnancy test within 72h pre-first dose; contraception during study + 6 months post-last dose. Males with fertile partners: contraception during study + 6 months post-last dose.

Who cannot join

  • Any unresolved NCI CTCAE ≥ grade 2 toxicity following prior chemoradiotherapy. Patients with irreversible and controllable hearing loss are eligible;
  • Small cell carcinoma, adenocarcinoma, or mixed carcinoma components in histology;
  • Grade ≥ 2 peripheral neuropathy based on NCI CTCAEv5.0 criteria
  • Found to have a higher risk of esophageal fistula by clinical assessment or imaging studies, such as a past history or related symptoms of esophageal fistula, or infiltration of the primary tumor into the great vessels or trachea;
  • Patients with any history of active autoimmune diseases or autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); patients without any intervention after adults except vitiligo or recovered childhood asthma/allergy; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes treated with stable doses of insulin can be included;
  • History of immunodeficiency, including positive HIV test, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation;
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  • Patients with uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II and above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;
  • Serious infection (CTCAE > grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging showed active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug need oral or intravenous antibiotics, but excluding the prophylactic use of antibiotics; through the history or CT examination found active pulmonary tuberculosis infection, or within 1 year before enrollment found active pulmonary tuberculosis infection history, or more than 1 year ago had active pulmonary tuberculosis infection history but no regular treatment of patients;
  • Known allergies, hypersensitivity, or contraindications to terdiplimumab or any of the components used in its formulation;
  • Diagnosis of any other malignancy before the first use of study drugs, except for those with a low risk of metastasis and death (5-year survival rate > 90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ;
  • Pregnant or lactating women; fertile subjects are unwilling or unable to take effective contraceptive measures;
  • According to the investigator 's judgment, the patient has other factors that may cause the patient to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental illness) requiring concomitant treatment, and recently combined with other serious diseases (such as myocardial infarction, cerebrovascular accident) considering the high risk of recurrence, severely abnormal laboratory test values, family or social factors, which may affect the patient' s safety or the collection of trial data.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Department of Radiation Oncology, Tianjin Medical University Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

    QING SONG PANG, M.D, +86-22-23340123-1314, pangqingsong@yahoo.com.cn

    Recruiting

Other trials in China

About this study

Official title: Stratified Treatment in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma Without Progression After Chemoimmunotherapy Induction Plus Concurrent Chemoradiotherapy: Toripalimab Consolidation vs observation--a Prospective, Randomized, Controlled Phase III Multicenter Study

This study is a prospective, randomized controlled, phase III multicenter trial. Its objectives are to explore the stratified application of consolidation immunotherapy after chemoimmunotherapy induction plus concurrent chemoradiotherapy, identify the potential beneficiary population of consolidation immunotherapy, and evaluate the efficacy and safety of consolidation immunotherapy.

The main participants are patients with unresectable locally advanced esophageal squamous cell carcinoma who have undergone 2-4 cycles of chemoimmunotherapy induction followed by concurrent chemoradiotherapy. Imaging assessment should be completed within 1-84 days after the end of chemoradiotherapy. Eligible patients meeting the inclusion and exclusion criteria will be divided into the CR/PR cohort and SD cohort based on treatment response, and receive the following treatments respectively:

Read more

CR/PR cohort: Patients with a response assessment of CR (Complete Response) or PR (Partial Response) will be randomly assigned at a 1:1 ratio to:

Toripalimab monotherapy maintenance group (Group A1) vs. Observation group (Group A2) (116 patients vs. 116 patients)

SD cohort: Patients with a response assessment of SD (Stable Disease) will be randomly assigned at a 1:1 ratio to:

Toripalimab monotherapy maintenance group (Group B1) vs. Observation group (Group B2) (54 patients vs. 54 patients) The medication dosage is as follows: Toripalimab 240mg, intravenous infusion on Day 1, every 3 weeks (Q3W). A total of 3 treatment cycles will be administered. Subsequent treatment continuation will be determined by the patient. If continued, treatment will proceed until the occurrence of disease progression (radiological progression confirmed by RECIST v1.1), intolerable toxicity, initiation of new antitumor therapy, voluntary withdrawal of the subject from the study, or the investigator's judgment that the subject needs to withdraw. The maximum duration of medication is 1 year.

Being tested
Toripalimab
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ToripalimabDrug

    Toripalimab 240 mg, administered on the first day of each cycle, and a cycle of administration every 3 weeks

Study groups in NCT07246330
Study groupRoleWhat they receive
A1ExperimentalNot described
Receives: Drug: Toripalimab
A2No interventionNot described
B1ExperimentalNot described
Receives: Drug: Toripalimab
B2No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1 year Progress Free Survival (PFS) rate

    PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression or death due to any cause.

    Measured: 12 months

Secondary outcomes (3)

  1. Progression free survival (PFS)

    PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression or death due to any cause.

    Measured: 36 months

  2. Overall survival (OS)

    OS is the length of time from the date of randomization until death from any cause

    Measured: 36 months

  3. Objective response rate (ORR)

    ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2025
  2. Study start23 Mar 2026
  3. Primary completion15 Dec 2027 (estimated)
  4. Study completion15 Dec 2029 (estimated)

Resources

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
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07246330
Sponsor's protocol ID
SELECTor
Status last verified
Nov 2025
First submitted
17 Nov 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Toripalimab in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

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 15 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1 year Progress Free Survival (PFS) rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07246330.

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 23 Oct 2026.

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