Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer

Trial Title: Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer

NCT ID: NCT05561699

Condition: Esophageal Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Squamous Cell

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Penpulimab Combined With CRT
Description: 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.
Arm group label: Penpulimab Combined With Chemoradiotherapy(CRT)

Summary: 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).

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Zhongshan Hospital

Address:
City: Shanghai
Zip: 200000
Country: China

Contact:
Last name: Jian Wang, MD

Phone: 0086-13816101686
Email: wang.jian3@zs-hospital.sh.cn

Start date: September 28, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: Shanghai Zhongshan Hospital
Agency class: Other

Source: Shanghai Zhongshan Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05561699