AzTrials
AzTrials

Esophageal Squamous Cell Carcinoma (ESCC)Phase 2NCT07403435

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

A Phase 2 study testing Serplulimab in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Serplulimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
15 Feb 2026to 31 May 2030
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 13Show fewer
  • 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.

Who cannot join

  • 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;
Show all 20Show fewer
  • 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;
  • Untreated active syphilis;
  • History of substance abuse with psychotropic drugs and unable to quit or with psychiatric disorders;
  • Pleural effusion or ascites with clinical symptoms requiring clinical intervention;
  • History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sheng Dr.Zhang, MD. PhD. contact

0086-139714426

tonydppx@hotmail.com

Rui Dr. Zhou, MD. PhD. contact

China1 site

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

    Wuhan, Hubei, 430022

    Sheng Zhang, Dr., 0086-13971442699, tonydppx@hotmail.com

Other trials in China

About this study

Official title: 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.

Being tested
Serplulimab
Keywords
Short-course radiotherapy, neoadjuvant, esophageal squamous cell carcinoma
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.

  • SerplulimabDrug

    Also called Albumin-bound paclitaxel, Cisplatin, Carboplatin

    Serplulimab (300mg) + Albumin-bound paclitaxel + Cisplatin/Carboplatin, Q3W, 3cycles

Study groups in NCT07403435
Study groupRoleWhat they receive
TreatmentExperimentalPTV:1.5Gy Bid,5 days Serplulimab (300mg) + Albumin-bound paclitaxel + Cisplatin/Carboplatin, Q3W, 3cycles
Receives: Drug: Serplulimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pCR（Pathological Complete Response）

    Definition of pathology complete response is "no cancer cell, including lympho nodes"

    Measured: within 14 working days after operation

Secondary outcomes (5)

  1. MPR（Major Pathological Remission rate）

    The residual tumor after neoadjuvant treatment ≤ 10% residual tumor lesion in surgical specimen compared to baseline.

    Measured: within 14 working days after operation

  2. ORR（Objective Response Rate）

    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)

    Measured: 3-4 weeks after the last cycle of neoadjuvant treatment

  3. Rate of R0 resection

    Measure the rate of R0 resection with all margins microscopically clear.

    Measured: within 14 working days after operation

  4. EFS (Events Free Survival)

    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

    Measured: The date from the beginning of randomization to the date of first record. 5 years EFS

  5. Safety assessment

    Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2026
  2. Study start15 Feb 2026 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2030 (estimated)

Resources

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
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07403435
Sponsor's protocol ID
HLX10IIT163
Status last verified
Feb 2026
First submitted
8 Sep 2025
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Serplulimab in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

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 13 inclusion and 20 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 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Sheng Dr.Zhang, MD. PhD. (0086-139714426, tonydppx@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR（Pathological Complete Response） (time frame: within 14 working days after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07403435.

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 11 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in