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
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;
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.
Single group
Toripalimab
DrugAfter 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.
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.
Overall Survival (OS)
defined as the period from the start of the study treatment to loss of follow-up or death
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.
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.
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