Short-course Radiotherapy Combined With Serplulimab and Chemotherapy as Neoadjuvant Treatment for Resectable ESCC
1 other identifier
interventional
22
1 country
1
Brief Summary
This study includes patients with resectable esophageal squamous cell carcinoma who will undergo local radiotherapy (PTV: 1.5Gy Bid, for 5 days), followed by neoadjuvant treatment with Serplulimab combined with cisplatin and paclitaxel for three cycles. Afterward, they will undergo surgery. Postoperatively, researchers will select adjuvant treatment plans based on the patients' conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2026
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2025
CompletedFirst Posted
Study publicly available on registry
February 11, 2026
CompletedStudy Start
First participant enrolled
February 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2030
February 11, 2026
February 1, 2026
1.3 years
September 8, 2025
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pCR（Pathological Complete Response）
Definition of pathology complete response is "no cancer cell, including lympho nodes"
within 14 working days after operation
Secondary Outcomes (5)
MPR（Major Pathological Remission rate）
within 14 working days after operation
ORR（Objective Response Rate）
3-4 weeks after the last cycle of neoadjuvant treatment
Rate of R0 resection
within 14 working days after operation
EFS (Events Free Survival)
The date from the beginning of randomization to the date of first record. 5 years EFS
Safety assessment
From the first dose of study drug up to 30 days after last dose of any component of treatment or surgery or the initiation of subsequent anticancer therapy, whichever occurred first. Up to approximately 9 months.
Study Arms (1)
Treatment
EXPERIMENTALPTV:1.5Gy Bid,5 days Serplulimab (300mg) + Albumin-bound paclitaxel + Cisplatin/Carboplatin, Q3W, 3cycles
Interventions
Serplulimab (300mg) + Albumin-bound paclitaxel + Cisplatin/Carboplatin, Q3W, 3cycles
Eligibility Criteria
You may qualify if:
- Patients with histologically confirmed squamous cell carcinoma of the esophagus (ESCC) staged as cT1-2N+M0 and cT3NanyM0 (AJCC 8th edition);
- Aged between 18-75 years;
- ECOG performance status score of 0-1;
- The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for study participation
- Hemoglobin ≥90g/L; ANC≥1.5×10\^9/L;platelet count ≥100×10\^9/L (patients must not have received blood transfusion or growth factor support within 14 days of blood sample collection);
- ALT, AST ≤2.5\*ULN; ALP ≤2.5\*ULN;
- Serum total bilirubin \<1.5\*ULN
- Serum creatinine \<1.5\*ULN or estimated glomerular filtration rate (eGFR) ≥60ml/min/1.73m\^2;
- Serum albumin ≥30g/L;
- INR or PT ≤1.5 \*ULN, unless the patient is on anticoagulant therapy and the PT is within the expected therapeutic range; g. Activated partial thromboplastin time (APTT) ≤1.5 times ULN.
- No severe concomitant diseases with a life expectancy of less than 5 years;
- Voluntary and able to comply with the study protocol during the study period;
- Provide written informed consent prior to entering the study, and the patient has been informed that they can withdraw from the study at any time without any loss.
You may not qualify if:
- History of other malignancies in the past or concurrently, except for cured basal cell carcinoma of the skin and in situ cervical carcinoma; patients with small gastric stromal tumors and other tumors judged by the investigator to not affect the patient's life in the short term may be excluded;
- Participation in other drug clinical trials within four weeks;
- Patients with any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaryitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that was completely resolved in childhood and does not require any intervention in adulthood may be included; asthma requiring medical intervention with bronchodilators cannot be included);
- Patients currently using immunosuppressants, or systemic corticosteroid therapy for immunosuppressive purposes (dose \>10mg/day prednisone or other equivalent corticosteroids), and continued use within two weeks prior to enrollment;
- Any active malignant tumor within two years, except for the specific cancer being studied in this trial and cured locally recurrent cancer (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, in situ cervical or breast carcinoma);
- Patients with known central nervous system (CNS) metastasis or history of CNS metastasis at screening. For patients clinically suspected of CNS metastasis, a CT or MRI examination must be performed within 28 days before treatment to rule out CNS metastasis;
- History of unstable angina; newly diagnosed angina within three months before screening or myocardial infarction event within six months before screening; arrhythmia (including QTcF: males ≥450 ms, females ≥470 ms) requiring long-term antiarrhythmic medication and New York Heart Association class ≥II heart failure;
- Urine routine indicating proteinuria ≥++ and confirmed 24-hour urinary protein \>1.0 g;
- For female subjects: should be surgically sterilized, postmenopausal patients, or agree to use a medically recognized contraceptive method during the study treatment period and for six months after the end of the study treatment; serum or urine pregnancy test must be negative within seven days before study enrollment, and must not be lactating. For male subjects: should be surgically sterilized, or agree to use a medically recognized contraceptive method during the study treatment period and for six months after the end of the study treatment;
- Patients who have undergone liver transplantation;
- Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia, and other patients requiring the use of corticosteroids;
- History of chronic autoimmune diseases, such as systemic lupus erythematosus;
- History of inflammatory bowel diseases such as ulcerative colitis, Crohn's disease, and history of chronic diarrheal diseases such as irritable bowel syndrome;
- History of sarcoidosis or tuberculosis;
- Active hepatitis B, hepatitis C, and HIV infection;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Rui Dr. Zhou, MD. PhD.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2025
First Posted
February 11, 2026
Study Start
February 15, 2026
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2030
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share