Esophageal Squamous Cell Carcinoma (ESCC)Phase 2NCT07272291
A Phase II Study of Toripalimab Plus Chemotherapy and Low-Dose Radiotherapy for Neoadjuvant Therapy-Refractory Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Toripalimab in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant toripalimab combined with chemotherapy and low-dose radiotherapy in patients with esophageal squamous cell carcinoma who are insensitive to neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- Toripalimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2025to 25 Dec 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged ≥ 18 years;
- Esophageal cancer staged as T1-4aN1-3M0 or T3-4aN0M0 (per AJCC 8th edition), with histologically confirmed predominant squamous cell carcinoma at initial diagnosis;
- Subjects must complete 2 cycles of preoperative neoadjuvant immunotherapy combined with chemotherapy (any regimen) before enrollment, followed by imaging assessment showing stable disease (SD);
- ECOG performance status score of 0 or 1;
- All required baseline laboratory tests must be completed, with results obtained within 14 days before enrollment. Laboratory tests resluts must meet the following criteria (per CTCAE v5):
- WBC ≥ 2000/μL Neutrophils ≥ 1500/μL Platelets ≥ 100 × 10³/μL Hemoglobin ≥ 9.0 g/dL Creatinine: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance > 50 mL/min (per Cockcroft/Gault formula) AST ≤ 3 × ULN, ALT ≤ 3 × ULN Total bilirubin ≤ 1.5 × ULN (except subjects with Gilbert syndrome, for whom total bilirubin must be < 3 × ULN);
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- Tumor tissue and blood must be provided for biomarker analysis. If the provided tumor tissue is insufficient for analysis, additional archived tumor tissue (blocks and/or sections) must be obtained;
- Subjects voluntarily participate in the study, sign a written informed consent form, and are compliant with follow-up;
- Subjects must be willing and able to adhere to scheduled visits, treatment plans, laboratory tests, tumor biopsies, and other study requirements;
- Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days before enrollment, and agree to use effective contraception during the study and for at least 6 months after the last dose of toripalimab. Males with partners of childbearing potential must agree to use effective contraception during the study and for at least 6 months after the last dose.
Who cannot join
- Subjects with a history of other malignant tumors are excluded, unless complete remission was achieved at least 5 years prior to study entry and no additional treatment is required or anticipated during the study period. Exceptions include, but are not limited to, basal or squamous cell carcinoma of the skin, superficial bladder cancer, or in situ carcinoma of the prostate, cervix, or breast.
- Subjects with known or suspected active autoimmune diseases are excluded. However, enrollment is permitted for subjects with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, cutaneous conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or conditions not expected to recur in the absence of external triggers.
- Subjects who required systemic treatment with corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive agents within 14 days prior to study drug administration are excluded. Inhaled or topical steroids, as well as adrenal replacement steroids, at doses exceeding 10 mg daily prednisone equivalent are allowed only in the absence of active autoimmune disease.
- Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity are excluded.
- All toxicities attributable to prior anticancer therapy (except nephropathy, neuropathy, hearing loss, alopecia, and fatigue) must resolve to Grade 1 (per NCI CTCAE Version 5) or baseline before study drug administration. Subjects with toxicities from prior anticancer therapy that are not expected to resolve and result in permanent sequelae (e.g., peripheral neuropathy following platinum-based therapy) are permitted, provided the peripheral neuropathy resolves to Grade 2 (per NCI CTCAE Version 5).
- Subjects with any severe or uncontrolled medical condition or active infection that, in the investigator's judgment, may increase the risks of study participation or study drug administration, or impair the subject's ability to complete treatment per the protocol are excluded.
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- Subjects with a known positive human immunodeficiency virus (HIV) test result or a confirmed diagnosis of acquired immunodeficiency syndrome (AIDS) are excluded.
- Subjects who received live/attenuated vaccines within 30 days prior to the first study treatment are excluded.
- Subjects with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are excluded, including those with: acute or chronic active hepatitis B/ C; HBV DNA >2000 IU/mL or 10⁴ copies/mL; HCV RNA >10³ copies/mL; or concurrent positivity for hepatitis B surface antigen (HBsAg) and anti-HCV antibodies.
- Subjects with a history of allergy or hypersensitivity to any component of the study drug, or a history of severe hypersensitivity to any monoclonal antibody are excluded.
- Subjects currently participating in other interventional clinical studies are excluded.
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: A Prospective, Single-Arm Phase II Study of Toripalimab Plus Chemotherapy and Low-Dose Radiotherapy as Neoadjuvant Treatment for Neoadjuvant Therapy-Refractory Esophageal Squamous Cell Carcinoma
The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant toripalimab combined with chemotherapy and low-dose radiotherapy in patients with esophageal squamous cell carcinoma who are insensitive to neoadjuvant therapy. The main question it aims to answer is:
- Whether adding low dose radiotherapy can improve the efficacy of immunotherapy combined chemotherapy in neoadjuvant setting?
Read more
Participants will receive low-dose radiotherapy (1.2 Gy/fraction, 5 fractions), followed by 2 cycles of chemotherapy plus toripalimab (240 mg, q3w). 6 to 8 weeks after treatment completion, a systematic preoperative assessment is conducted, then surgery is performed. Postoperatively, management depends on pathological results:
Non-pathological complete response (non-pCR) patients: Toripalimab monotherapy continues until disease recurrence, intolerable toxicity, informed consent withdrawal, or for 1 year (whichever comes first).
Pathological complete response (pCR) patients: Directly undergo regular postoperative survival follow-up
- 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
After 2 cycles of neoadjuvant therapy with stable disease (SD) in efficacy assessment, subjects will sign the informed consent form. Baseline assessment is conducted within 4 weeks before enrollment.
Enrolled patients first receive low-dose radiotherapy (1.2 Gy × 5), then continue with 2 cycles of the chemotherapy regimen combined with toripalimab (240 mg, once every 3 weeks), followed by surgical treatment.
Subsequently, based on pathological results:
Non-pCR patients receive toripalimab monotherapy until disease recurrence, intolerable toxicity, or subject's withdrawal of informed consent. The total duration of study drug administration is at most 1 year, whichever comes first.
pCR patients directly undergo regular post-surgical survival follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response (MPR) rate
MPR rate is defined as the proportion of participants who have achieved major pathological response（on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy and underwent surgery.
Measured: up to 12 months
Secondary outcomes (3)
Overall Survival (OS)
defined as the period from the start of the study treatment to loss of follow-up or death
Measured: up to 5 years
Pathological Complete Response (pCR) rate
Defined as the proportion of patients in postoperative pathology who have no residual live tumor cells in the primary tumor bed or in all excised lymph nodes.
Measured: up to 12 months
Event Free Survival (EFS)
EFS is defined as the time from the start of the study treatment to any of the following events (whichever occurs first): the investigator assessed the disease progression based on imaging according to RECIST 1.1 and therefore was unable to receive curative surgery, local or distant recurrence, or death from any cause.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start25 Dec 2025 (estimated)
- Primary completion25 Dec 2027 (estimated)
- Study completion25 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell Carcinoma (ESCC)Studies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272291
- Sponsor's protocol ID
- ESCC-TCR-2025
- Status last verified
- Sep 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm Phase II Study of Toripalimab Plus Chemotherapy and Low-Dose Radiotherapy as Neoadjuvant Treatment for Neoadjuvant Therapy-Refractory Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07272291
- Acronym / sponsor ID
- ESCC-TCR-2025
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- 25 Dec 2027 (estimated)
- Study completion
- 25 Dec 2028 (estimated)
- First posted
- 9 Dec 2025 (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.
The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant toripalimab combined with chemotherapy and low-dose radiotherapy in patients with esophageal squamous cell carcinoma who are insensitive to neoadjuvant therapy. The main question it aims to answer is:
- Whether adding low dose radiotherapy can improve the efficacy of immunotherapy combined chemotherapy in neoadjuvant setting?
Participants will receive low-dose radiotherapy (1.2 Gy/fraction, 5 fractions), followed by 2 cycles of chemotherapy plus toripalimab (240 mg, q3w). 6 to 8 weeks after treatment completion, a systematic preoperative assessment is conducted, then surgery is performed. Postoperatively, management depends on pathological results:
Non-pathological complete response (non-pCR) patients: Toripalimab monotherapy continues until disease recurrence, intolerable toxicity, informed consent withdrawal, or for 1 year (whichever comes first).
Pathological complete response (pCR) patients: Directly undergo regular postoperative survival follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Toripalimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females aged ≥ 18 years;
- Esophageal cancer staged as T1-4aN1-3M0 or T3-4aN0M0 (per AJCC 8th edition), with histologically confirmed predominant squamous cell carcinoma at initial diagnosis;
- Subjects must complete 2 cycles of preoperative neoadjuvant immunotherapy combined with chemotherapy (any regimen) before enrollment, followed by imaging assessment showing stable disease (SD);
- ECOG performance status score of 0 or 1;
- All required baseline laboratory tests must be completed, with results obtained within 14 days before enrollment. Laboratory tests resluts must meet the following criteria (per CTCAE v5):
Key exclusion criteria (11 listed)
- Subjects with a history of other malignant tumors are excluded, unless complete remission was achieved at least 5 years prior to study entry and no additional treatment is required or anticipated during the study period. Exceptions include, but are not limited to, basal or squamous cell carcinoma of the skin, superficial bladder cancer, or in situ carcinoma of the prostate, cervix, or breast.
- Subjects with known or suspected active autoimmune diseases are excluded. However, enrollment is permitted for subjects with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, cutaneous conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or conditions not expected to recur in the absence of external triggers.
- Subjects who required systemic treatment with corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive agents within 14 days prior to study drug administration are excluded. Inhaled or topical steroids, as well as adrenal replacement steroids, at doses exceeding 10 mg daily prednisone equivalent are allowed only in the absence of active autoimmune disease.
- Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity are excluded.
- All toxicities attributable to prior anticancer therapy (except nephropathy, neuropathy, hearing loss, alopecia, and fatigue) must resolve to Grade 1 (per NCI CTCAE Version 5) or baseline before study drug administration. Subjects with toxicities from prior anticancer therapy that are not expected to resolve and result in permanent sequelae (e.g., peripheral neuropathy following platinum-based therapy) are permitted, provided the peripheral neuropathy resolves to Grade 2 (per NCI CTCAE Version 5).
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 |
|---|---|---|
| ToripalimabAfter 2 cycles of neoadjuvant therapy with stable disease (SD) in efficacy assessment, subjects will sign the informed consent form. Baseline assessment is conducted within 4 weeks before enrollment. Enrolled patients first receive low-dose radiotherapy (1.2 Gy × 5), then continue with 2 cycles of the chemotherapy regimen combined with toripalimab (240 mg, once every 3 weeks), followed by surgical treatment. Subsequently, based on pathological results: Non-pCR patients receive toripalimab monotherapy until disease recurrence, intolerable toxicity, or subject's withdrawal of informed consent. The total duration of study drug administration is at most 1 year, whichever comes first. pCR patients directly undergo regular post-surgical survival follow-up. | Drug | Experimental Arm |
Primary outcome
Major Pathological Response (MPR) rate
Time frame: up to 12 months
MPR rate is defined as the proportion of participants who have achieved major pathological response（on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy and underwent surgery.
3 secondary outcomes
Overall Survival (OS)
Time frame: up to 5 years
Pathological Complete Response (pCR) rate
Time frame: up to 12 months
Event Free Survival (EFS)
Time frame: up to 5 years
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 9 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Tianjin Medical University Cancer Institute and 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 10 inclusion and 11 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 9 Dec 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Lei Gong, M.D./PhD. (+8618526812877, 18526812877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (MPR) rate (time frame: up to 12 months). 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 9 Dec 2025.