- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05561699
Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer (SPEED)
September 28, 2022 updated by: Shanghai Zhongshan Hospital
Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer: A Prospective, Single Arm, Single Center,Exploratory Study
This study used an open single center study design to observe the efficacy and safety of Penpulimab combined with Chemoradiotherapy(CRT) in preoperative T2,3,4aN0-1-2M0 esophageal squamous cell carcinoma (ESCC).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
66
Phase
- Not Applicable
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
- Name: Yang Qian, MD
- Phone Number: 0086-13817929371
- Email: qy19792006@163.com
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200000
- Zhongshan Hospital
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Contact:
- Jian Wang, MD
- Phone Number: 0086-13816101686
- Email: wang.jian3@zs-hospital.sh.cn
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-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Resectable t2,3,4an0-1-2m0 esophageal squamous cell carcinoma initially diagnosed by histology or cytology;
- Without any systematic anti-tumor treatment;
- ECOG 0-1;
- ANC≥ 1.5×109/L;
- PLT≥ 75×109/L;
- HB≥ 8.0 g/dL;
- TBIL ≤ 1.5´ ULN;
- ALT and AST ≤ 2.5´ULN;
- Cr ≤ 1.5´ULN or CCr ≥ 60ml/min;
- Urine protein < +, if urine protein + then the total protein in 24 hours must be <500mg;
- Blood glucose is within the normal range and / or patients with diabetes are in treatment, but blood glucose is controlled in a stable state;
- FEV1 ≥ 2L; If the baseline FEV1 is less than 2L, it is estimated that the FEV1 after surgery is greater than 800ml;
- No myocardial infarction within 1 year; No unstable angina pectoris; No symptomatic severe arrhythmia; No cardiac insufficiency;
- There are no serious complications or other major diseases that have not been cured;
- Thoracic surgeons judge those who can tolerate the operation;
- Female subjects with fertility and male subjects with partners of childbearing age need to use a medically approved contraceptive measure during the study treatment and at least 6 months after the last chemotherapy;
- The subjects voluntarily joined the study and signed the informed consent form
Exclusion Criteria:
- Received any kind of systematic anti-tumor treatment before the first use of the study drug;
- At the same time, another clinical study will be included, unless it is an observational (non intervention) clinical study;
- Subjects who need to be given corticosteroids (more than 10mg prednisone equivalent dose per day) or other immunosuppressants for systematic treatment within 2 weeks before the first use of the study drug;
- Have been vaccinated with tumor vaccine or have been vaccinated with live vaccine within 4 weeks before administration;
- Have a history of active autoimmune diseases and autoimmune diseases; Except for patients who have recovered from childhood asthma / allergy and do not need any intervention after adulthood; Autoimmune mediated hypothyroidism treated with a stable dose of thyroid hormone replacement; Use a stable dose of insulin for type I diabetes;
- Serious interference occurred within 4 weeks before the first use of the study drug (CTC AE>2); Baseline chest imaging examination showed active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug, or the need for oral or intravenous antibiotics;
- Have a history of interstitial lung disease;
- The subjects had active hepatitis B (HBV DNA ≥ 2000 IU/ml or 104copies/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the lower limit of the analysis method);
- Pregnant or lactating women;
- There are serious complications or other major diseases that have not been cured;
- Patients judged by thoracic surgeons to be intolerant of surgery
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: Penpulimab Combined With Chemoradiotherapy(CRT)
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pathological complete remission(pCR)rate
Time Frame: 3 to 4 months
|
Proportion of subjects who achieved pathological complete remission (PCR),PCR was defined as the microscopic absence of tumor cells in the pathological evaluation of excised esophageal cancer lesions and regional lymph node samples after surgery.
|
3 to 4 months
|
safety(AE or SAE)
Time Frame: 2 to 3 years from baseline
|
Incidence of adverse events or serious adverse events
|
2 to 3 years from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor regression grade(TRG)
Time Frame: 3 to 4 months
|
Evaluation of the focus of primary tumor after radiotherapy and chemotherapy
|
3 to 4 months
|
R0 resection rate
Time Frame: 3 to 4 months
|
Proportion of subjects reaching R0 resection.
resection was defined as no tumor cells remained within 1mm of the two cutting edges of the esophageal cancer lesions removed during the operation.
|
3 to 4 months
|
Event free survival(EFS)
Time Frame: 2 to 3 years from baseline
|
Date of first administration to date of first recording of relevant events
|
2 to 3 years from baseline
|
Overall survival(OS)
Time Frame: 2 to 3 years from baseline
|
Date of first administration to date of death due to any cause
|
2 to 3 years from baseline
|
Disease free survival(DFS)
Time Frame: 2 to 3 years from baseline
|
Date from the operation to the first recording of relevant events
|
2 to 3 years from baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jian Wang, MD, Fudan University
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 (Anticipated)
September 28, 2022
Primary Completion (Anticipated)
September 30, 2024
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
September 28, 2022
First Submitted That Met QC Criteria
September 28, 2022
First Posted (Actual)
September 30, 2022
Study Record Updates
Last Update Posted (Actual)
September 30, 2022
Last Update Submitted That Met QC Criteria
September 28, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
- Neoplasms, Squamous Cell
Other Study ID Numbers
- B2022-143R2
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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