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

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

Study Locations

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)
  1. Penpulimab: 200mg, intravenous infusion, once every two weeks. After completing two courses of CRT, continue to send Penpulimab 200mg every two weeks on the first and 14th days after the completion of CRT, two courses of treatment, a total of four courses.
  2. Radiotherapy 40gy/20fx, once a day from Monday to Friday, completed in 4 weeks;
  3. PC regimen: Paclitaxel 50mg/m2, intravenous drip, carboplatin AUC=2mg/ml/min, intravenous drip, once a week during radiotherapy, a total of 4 courses, the specific time is D1, 8, 15, 22 days after the beginning of radiotherapy.
  4. Gastrointestinal reactions such as nausea and vomiting should be routinely prevented before chemotherapy. Dexamethasone 10mg should be used 30 ~ 60 minutes before paclitaxel, and intramuscular injection should be stopped immediately in case of drug or infusion reactions.

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.

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

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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