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AzTrials

Esophageal Squamous Cell CarcinomaPhase 2NCT05659251

Serplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Serplulimab, Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapy, Esophagectomy and sample in people with Esophageal Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Serplulimab, Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapy, Esophagectomy and sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
1 Dec 2022to 31 Dec 2029
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

  • signed informed consent;
  • patients age 18 to 75 years old
  • primary resectable, histologically confirmed esophageal squamous cell cancer;
  • Esophageal squamous cell carcinoma the clinical stage was IIA-IVA (according to AJCC TNM stage, 8th edition).
  • ECOG PS 0-1.
  • No distant metastasis, the diseases could be resectable assessed by thoracic oncologist;

Who cannot join

  • with significant cardiovascular disease;
  • current treatment with anti-viral therapy or HBV;
  • Female patients who are pregnant or lactating;
  • history of malignancy within 5 years prior to screening;
  • active or history of autoimmune disease or immune deficiency;
  • signs of distant metastases.

Trial locations and contacts

1 site in 1 country.

China1 site

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, China, 310009

Other trials in China

About this study

Official title: A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Serplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma

China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased. For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of esophageal cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that serplulimab provided higher overall response rate for advanced esophageal cancer. However, in patients with locally advanced esophageal cancer, the efficacy of serplulimab combined with chemotherapy for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of silulimab combined with chemotherapy in the neoadjuvant therapy of resectable esophageal squamous cell carcinoma.

Being tested
Serplulimab, Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapy, Esophagectomy, sample
Keywords
serplulimab, Esophageal Squamous Cell Carcinoma, Neoadjuvant Treatment
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.

  • Serplulimab, Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapyCombination product

    Serplulimab 4.5mg/kg, IV, Day 1; Albumin paclitaxel 260mg/m2, Day 1; carboplatin AUC=5, Day 1; Preoperative neoadjuvant therapy for 3 cycles, one cycle every 21 days.

  • EsophagectomyProcedure or surgery

    Prior to each surgical procedure, the department engaged in comprehensive discussions and deliberations to ascertain and establish the most suitable course of action. Minimally invasive Ivor-Lewis (intrathoracic anastomosis) or McKeown (neck anastomosis) esophagectomy, including two field extensive lymphadenectomies, was performed according to the tumor location. The resection length should be at least 5cm from the tumor origin according to prechemotherapy by endoscopy.

    The surgeries will be performed by surgeons with rich experience. Minimally invasive esophagectomy, can be performed using the da Vinci surgical robot, thoracoscope, or laparoscope, or by using an open approach, as judged appropriate by the surgeon.

  • sampleOther

    Blood, Tumour will be Collected from participant. Fate of sample is Destruction after use.

    5 ml of peripheral blood was collected the day before each of the immunotherapy sessions and after surgery.

    Tumour sample will be collected before neoadjuvant therapy and after surgery.

Study groups in NCT05659251
Study groupRoleWhat they receive
SerplulimabExperimentalPreoperative neoadjuvant therapy for 3 cycles. Radical surgery is performed 4-6 weeks after the last dose. Postoperative radiotherapy is determined according to the clinical situation and pathological stage of the patient. Serplulimab can be maintained for a maximum of 1 year. During the study, patients were be followed until disease progression, withdrawal of informed consent, loss of follow-up, or death.
Receives: Combination Product: Serplulimab, Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapy; Procedure: Esophagectomy; Other: sample

What is being measured

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

  1. Pathological Complete Response (PCR)

    No residual invasive tumor cells were found in the pathological examination of resected specimens, including the primary tumor and lymph nodes.

    Measured: 1 month after surgery

Secondary outcomes (6)

  1. major pathological response (MPR)

    In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.

    Measured: 1 month after surgery

  2. Objective Response Rate (ORR)

    The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria

    Measured: before surgery

  3. 2-year and 5-year overall survival

    The proportion of all study cases in which no death from any cause occurred within 2 years and 5 years after surgery

    Measured: 2-year and 5-year after surgery

  4. Incidence of Treatment-related Adverse Events

    Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0

    Measured: 1 month after surgery

  5. R0 resection rate

    The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope

    Measured: 1 month after surgery

  6. The changes in the peripheral blood immunoprofile and tumor tissue sample among non-PCR (NPCR) and PCR patients

    By using mass spectrometry (CyTOF) and single-cell analysis, we comprehensively characterized the immune landscape in the peripheral blood and tumor sample of ESCC patients before and after anti-PD-1 immunotherapy, aiming to explore the immune subsets correlated with neoadjuvant immunotherapy response.

    Measured: 3 months after surgery

Timeline

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

  1. First posted21 Dec 2022
  2. Study start1 Dec 2022
  3. Primary completion31 Oct 2024
  4. Study completion31 Dec 2029 (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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05659251
Sponsor's protocol ID
2022-1022
Status last verified
Nov 2025
First submitted
13 Dec 2022
Last updated
2 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wu Z, Wu C, Wang Y, Liang F, Qi L, Wang K, Shen G, Li J, Shen H, Wu M. Neoadjuvant serplulimab combined with chemotherapy for resectable oesophageal squamous cell carcinoma: a single-arm, phase 2 trial. Nat Commun. 2025 Dec 21;17(1):871. doi: 10.1038/s41467-025-67589-5.

    PubMed 41423619

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Serplulimab, Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapy, Esophagectomy and sample in people with Esophageal Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response (PCR) (time frame: 1 month after surgery). 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 NCT05659251, which also lists 1 linked publication.

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 2 Dec 2025.

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