Clinical trial NCT05561699: Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer
Official title: Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer: A Prospective, Single Arm, Single Center，Exploratory Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: pathological complete remission（pCR）rate
timeFrame: 3 to 4 months
measure: safety（AE or SAE）
timeFrame: 2 to 3 years from baseline
Secondary outcomes:
measure: Tumor regression grade（TRG）
timeFrame: 3 to 4 months
measure: R0 resection rate
timeFrame: 3 to 4 months
measure: Event free survival（EFS）
timeFrame: 2 to 3 years from baseline
measure: Overall survival（OS）
timeFrame: 2 to 3 years from baseline
measure: Disease free survival（DFS）
timeFrame: 2 to 3 years from baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jian Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: