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

Fudan University

Status

Not yet enrolling

Conditions

Esophageal Squamous Cell Carcinoma

Treatments

Drug: Penpulimab Combined With CRT

Study type

Interventional

Funder types

Other

Identifiers

NCT05561699

B2022-143R2

Details and patient eligibility

About

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).

Enrollment

66 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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