Esophageal Squamous Cell CarcinomaPhase 4NCT06388135
Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma
A Phase 4 study testing Serplulimab Combined With Nab-paclitaxel and Cisplatin and nab-paclitaxel，Cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Yang Jianjun, PhD.
Trial summary
Abstract Objective: This study aims to investigate the potential clinical impact of neoadjuvant immunotherapy in resectable esophageal squamous cell carcinoma (ESCC). The efficacy and safety of combining the programmed death 1 (PD-1) inhibitor serplulimab with nab-paclitaxel and cisplatin as neoadjuvant therapy in… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Serplulimab Combined With Nab-paclitaxel and Cisplatin and nab-paclitaxel，Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to May 2027
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age range of the enrolled patients was 18-70 years;
- ECOG score 0-1 ;
- Patients with ESCC diagnosed by pathology (histology or cytology);
- Resectable IB-III (cT1b~3N1-2M0 or cT3~4aN0~1M0) stage per the 8th edition of clinical TNM staging;
- Measurable lesions (per RECIST 1.1 criteria: major tumor diameter on CT scan ≥10mm, short lymph node diameter on CT scan ≥15mm);
- No prior radiotherapy, chemotherapy, surgery, or targeted therapy;
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- Surgical tolerance and ability to consume liquid diet without esophageal complications;
- Normal major organ function criteria: (1) Blood tests: ANC ≥ 1.5 × 109/L, PLT ≥ 100 × 109/L, HB ≥ 90 g/L; (2) Biochemical tests: TBIL≤1.5×ULN, ALT/AST≤ 2.5×ULN, serum creatinine ≤1.5×ULN, ALB ≥ 30 g/L; (3) Coagulation function: INR≤1.5×ULN, APTT≤1.5×ULN;
- Normal or mildly to moderately abnormal lung function suitable for EC surgery: A) VC%>60%, B) FEV1>1.2L, FEV1%>40%, C) DLCO>40%;
- Voluntary participation with informed consent and good compliance.
- The exclusion criteria were as follows:
- Any current or past presence of autoimmune diseases;
- Patients with immune deficiency disorders like HIV infection, active hepatitis B (HBV DNA ≥ 500 IU/ML), hepatitis C (HCV antibody positive, and HCV-RNA above the detection limit), or co-infection with hepatitis B and hepatitis C;
- Patients who have taken immunosuppressive drugs within 14 days before enrollment; patients who experienced a weight loss of ≥10% within 6 months prior to enrollment, or have a BMI below 18.5kg/m2, or have a PG-SGA score indicating grade C;
- Patients who had attenuated live vaccines within 4 weeks before enrollment;
- History of other cancers;
- Patients with myocardial infarction within six months before enrollment or diagnosed with New York Heart Association grade ≥ II heart failure;
- Patients who have experienced severe infections or undergone allogeneic organ transplantation or hematopoietic stem cell transplantation within the 4 weeks preceding enrollment;
- Patients with substance abuse, alcohol consumption, or psychotropic substance use.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma: a Study Protocol of Prospective Single-center, Open Label and Exploratory Cohort Study (SNC-01)
Abstract Objective: This study aims to investigate the potential clinical impact of neoadjuvant immunotherapy in resectable esophageal squamous cell carcinoma (ESCC).
The efficacy and safety of combining the programmed death 1 (PD-1) inhibitor serplulimab with nab-paclitaxel and cisplatin as neoadjuvant therapy in patients with resectable ESCC will be evaluated. Methods and analysis: A prospective, single-center, open-label cohort study will enroll 80 patients, with 40 patients allocated to the experimental group and 40 patients to the control group. Patients in the experimental arm will undergo 3 cycles of neoadjuvant therapy comprising serplulimab, cisplatin, and nab-paclitaxel, while those in the control arm will receive 3 cycles of neoadjuvant therapy with cisplatin and nab-paclitaxel. The primary efficacy endpoint will be the assessment of pathological complete response (pCR) following neoadjuvant therapy. Secondary efficacy endpoints will include major pathological response (MPR), disease-free survival, objective response rate (ORR), and monitoring of adverse events (AEs).
Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20242052-C-1).
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Serplulimab Combined With Nab-paclitaxel and Cisplatin, nab-paclitaxel，Cisplatin
- 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 Combined With Nab-paclitaxel and CisplatinDrug
Serplulimab (200 mg), cisplatin (60-75 mg/m2), and nab-paclitaxel (135 mg/m2) administered intravenously at the beginning of every 3-week cycle.
nab-paclitaxel，CisplatinDrug
nab-paclitaxel，Cisplatin
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab，nab-paclitaxel，Cisplatin | Experimental | Serplulimab (200 mg), cisplatin (60-75 mg/m2), and nab-paclitaxel (135 mg/m2) administered intravenously at the beginning of every 3-week cycle Receives: Drug: Serplulimab Combined With Nab-paclitaxel and Cisplatin |
| nab-paclitaxel，Cisplatin | Sham comparator | Cisplatin (60-75 mg/m2) and nab-paclitaxel (135 mg/m2) given intravenously at the beginning of every 3-week cycle. Receives: Drug: nab-paclitaxel，Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
pathological Complete Response
Measured: after surgery,within 12 weeks
Secondary outcomes (4)
MPR
major pathologic response
Measured: after surgery,within 12 weeks
DFS
Disease free survival
Measured: up to 24 months
ORR
objective response rate
Measured: up to 24 months
AEs
adverse events
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yang Jianjun, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Jianjun, PhD, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388135
- Sponsor's protocol ID
- SNC-01
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma: a Study Protocol of Prospective Single-center, Open Label and Exploratory Cohort Study (SNC-01)
- ClinicalTrials.gov ID
- NCT06388135
- Acronym / sponsor ID
- SNC-01
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yang Jianjun, PhDUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Abstract Objective: This study aims to investigate the potential clinical impact of neoadjuvant immunotherapy in resectable esophageal squamous cell carcinoma (ESCC).
The efficacy and safety of combining the programmed death 1 (PD-1) inhibitor serplulimab with nab-paclitaxel and cisplatin as neoadjuvant therapy in patients with resectable ESCC will be evaluated. Methods and analysis: A prospective, single-center, open-label cohort study will enroll 80 patients, with 40 patients allocated to the experimental group and 40 patients to the control group. Patients in the experimental arm will undergo 3 cycles of neoadjuvant therapy comprising serplulimab, cisplatin, and nab-paclitaxel, while those in the control arm will receive 3 cycles of neoadjuvant therapy with cisplatin and nab-paclitaxel. The primary efficacy endpoint will be the assessment of pathological complete response (pCR) following neoadjuvant therapy. Secondary efficacy endpoints will include major pathological response (MPR), disease-free survival, objective response rate (ORR), and monitoring of adverse events (AEs).
Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20242052-C-1).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serplulimab，nab-paclitaxel，Cisplatin | Experimental | Drug: Serplulimab Combined With Nab-paclitaxel and CisplatinSerplulimab (200 mg), cisplatin (60-75 mg/m2), and nab-paclitaxel (135 mg/m2) administered intravenously at the beginning of every 3-week cycle |
| nab-paclitaxel，Cisplatin | Sham comparator | Drug: nab-paclitaxel，CisplatinCisplatin (60-75 mg/m2) and nab-paclitaxel (135 mg/m2) given intravenously at the beginning of every 3-week cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- The age range of the enrolled patients was 18-70 years;
- ECOG score 0-1 ;
- Patients with ESCC diagnosed by pathology (histology or cytology);
- Resectable IB-III (cT1b~3N1-2M0 or cT3~4aN0~1M0) stage per the 8th edition of clinical TNM staging;
- Measurable lesions (per RECIST 1.1 criteria: major tumor diameter on CT scan ≥10mm, short lymph node diameter on CT scan ≥15mm);
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serplulimab Combined With Nab-paclitaxel and CisplatinSerplulimab (200 mg), cisplatin (60-75 mg/m2), and nab-paclitaxel (135 mg/m2) administered intravenously at the beginning of every 3-week cycle. | Drug | Serplulimab，nab-paclitaxel，Cisplatin |
| nab-paclitaxel，Cisplatinnab-paclitaxel，Cisplatin | Drug | nab-paclitaxel，Cisplatin |
Primary outcome
pCR
Time frame: after surgery,within 12 weeks
pathological Complete Response
4 secondary outcomes
MPR
Time frame: after surgery,within 12 weeks
DFS
Time frame: up to 24 months
ORR
Time frame: up to 24 months
AEs
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Serplulimab Combined With Nab-paclitaxel and Cisplatin and nab-paclitaxel，Cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Yang Jianjun, PhD.
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 19 inclusion and 0 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Wang Juan, ph.D (29-84771531, wangjuan861016@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: after surgery,within 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2024.