Short-course Radiotherapy Combined With Serplulimab and Chemotherapy as Neoadjuvant Treatment for Resectable ESCC

February 4, 2026 updated by: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Short-course Radiotherapy Combined With Serplulimab and Chemotherapy as Neoadjuvant Treatment for Resectable Esophageal Squamous Cell Carcinoma: a Single-center, Open-label Phase II Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Rui Dr. Zhou, MD. PhD.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with histologically confirmed squamous cell carcinoma of the esophagus (ESCC) staged as cT1-2N+M0 and cT3NanyM0 (AJCC 8th edition);
  2. Aged between 18-75 years;
  3. ECOG performance status score of 0-1;

  4. The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for study participation

    1. 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);
    2. ALT, AST ≤2.5*ULN; ALP ≤2.5*ULN;
    3. Serum total bilirubin <1.5*ULN
    4. Serum creatinine <1.5*ULN or estimated glomerular filtration rate (eGFR) ≥60ml/min/1.73m^2;
    5. Serum albumin ≥30g/L;
    6. 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.
  5. No severe concomitant diseases with a life expectancy of less than 5 years;
  6. Voluntary and able to comply with the study protocol during the study period;
  7. 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.

Exclusion Criteria:

  1. 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;
  2. Participation in other drug clinical trials within four weeks;
  3. 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);
  4. 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;
  5. 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);
  6. 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;
  7. 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;
  8. Urine routine indicating proteinuria ≥++ and confirmed 24-hour urinary protein >1.0 g;
  9. 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;
  10. Patients who have undergone liver transplantation;
  11. Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia, and other patients requiring the use of corticosteroids;
  12. History of chronic autoimmune diseases, such as systemic lupus erythematosus;
  13. History of inflammatory bowel diseases such as ulcerative colitis, Crohn's disease, and history of chronic diarrheal diseases such as irritable bowel syndrome;
  14. History of sarcoidosis or tuberculosis;
  15. Active hepatitis B, hepatitis C, and HIV infection;
  16. Untreated active syphilis;
  17. History of substance abuse with psychotropic drugs and unable to quit or with psychiatric disorders;
  18. Pleural effusion or ascites with clinical symptoms requiring clinical intervention;
  19. History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
  20. According to the investigator's judgment, there are serious concomitant diseases that endanger patient safety or affect the patient's ability to complete the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
PTV:1.5Gy Bid,5 days Serplulimab (300mg) + Albumin-bound paclitaxel + Cisplatin/Carboplatin, Q3W, 3cycles
Drug: Serplulimab
Serplulimab (300mg) + Albumin-bound paclitaxel + Cisplatin/Carboplatin, Q3W, 3cycles
Other Names:
  • Cisplatin
  • Carboplatin
  • Albumin-bound paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pCR（Pathological Complete Response）
Time Frame: within 14 working days after operation
Definition of pathology complete response is "no cancer cell, including lympho nodes"
within 14 working days after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MPR（Major Pathological Remission rate）
Time Frame: within 14 working days after operation
The residual tumor after neoadjuvant treatment ≤ 10% residual tumor lesion in surgical specimen compared to baseline.
within 14 working days after operation
ORR（Objective Response Rate）
Time Frame: 3-4 weeks after the last cycle of neoadjuvant treatment
The Objective Response Rate (ORR) will be defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) (RECIST V1.1)
3-4 weeks after the last cycle of neoadjuvant treatment
Rate of R0 resection
Time Frame: within 14 working days after operation
Measure the rate of R0 resection with all margins microscopically clear.
within 14 working days after operation
EFS (Events Free Survival)
Time Frame: The date from the beginning of randomization to the date of first record. 5 years EFS
The time from the start of treatment until any of the following events occur: any disease progression that prevents surgery, postoperative disease progression or recurrence, or death due to any cause
The date from the beginning of randomization to the date of first record. 5 years EFS
Safety assessment
Time Frame: 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.
Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2030

Study Registration Dates

First Submitted

September 8, 2025

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLX10IIT163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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