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

NCT05561699 | Unknown

• 1 other identifier: B2022-143R2
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• pathological complete remission（pCR）rate

  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）

  Incidence of adverse events or serious adverse events

  2 to 3 years from baseline

Secondary Outcomes (5)

• Tumor regression grade（TRG）

  3 to 4 months

• R0 resection rate

  3 to 4 months

• Event free survival（EFS）

  2 to 3 years from baseline

• Overall survival（OS）

  2 to 3 years from baseline

• Disease free survival（DFS）

  2 to 3 years from baseline

Study Arms (1)

Penpulimab Combined With Chemoradiotherapy(CRT)

EXPERIMENTAL

Drug: Penpulimab Combined With CRT

Interventions

Penpulimab Combined With CRT DRUG

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.

Penpulimab Combined With Chemoradiotherapy(CRT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Jian Wang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Qian, MD

CONTACT

0086-13817929371; qy19792006@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: September 30, 2022
• Study Start: September 28, 2022
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 30, 2022

Record last verified: 2022-08

Locations

CN (1)