Stratified Treatment in Unresectable Locally Advanced ESCC Without Progression After Chemoimmunot… (NCT07246330) | Clinical Trial Compass
Not Yet RecruitingPhase 3
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
340 participantsStarted 2025-12-15
Plain-language 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, 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:
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1 year Progress Free Survival (PFS) rate
Timeframe: 12 months
Trial details
NCT IDNCT07246330
SponsorTianjin Medical University Cancer Institute and Hospital
. 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;
. Adequate organ and bone marrow function defined as:
. ANC ≥1.5×10⁹/L;
Exclusion criteria
. 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;
. 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;