Toripalimab With Neoadjuvant Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

University of Electronic Science and Technology of China (UESTC)

Status and phase

Unknown

Phase 2

Conditions

Esophageal Squamous Cell Carcinoma

Treatments

Drug: Toripalimab

Study type

Interventional

Funder types

Other

Identifiers

NCT04177797

SCCH-TS2001

Details and patient eligibility

About

This is a single-institution, single arm trial of Toripalimab with neoadjuvant carboplatin and paclitaxel for locally advanced esophageal squamous cell carcinoma (ESCC).The primary study hypothesis is that the patients who received Toripalimab combined with carboplatin and paclitaxel will increase complete pathologic response rate.

Full description

Enrolled patinets will receive two cycles of Toripalimab(240 mg administered as an intravenous infusion over 30 minutes per 3 weeks), paclitaxel(135 mg/m2) and carboplatin(AUC 5) administered as an intravenous infusion per 3 weeks. Giving the drugs on the first day of each cycle.

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1.Histologically confirmed ESCC;
2.Clinical stage T1-2N2-3M0 or T3N1-3M0 or T4N0-3M0(AJCC 8 TNM classification);
3.Have a performance status of 0 or 1 on the ECOG Performance Scale;
4.The important organs functions meet the following requirements:the absolute neutrophil count(ANC) ≥1.5×109/L; the platelet count ≥100×109/L; hemoglobin ≥90g/L; bilirubin is less than or equal to 1.5 times ULN, ALT and AST less than or equal 2.5 times UILN; creatinine clearance rate(CCr) ≥50mL/min; the thyroid function is normal;
5.Expected survival time is greater than or equal to 3 months;
6.Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
7.Female subjects of childbearing potential must be willing to use an adequate method of contraception - Contraception, for the course of the study through 90 days after the last dose of study medication;
8.Be willing and able to provide written informed consent/assent for the trial.

Exclusion criteria

1.Has any active autoimmune disease or a history of autoimmune disease;
2.The patient is receiving systemic steroid therapy or any other form of immunosuppressive therapy;
3.The patient had active infection, fever of unknown cause ≥38.5℃ within 7 days before the medication, or white blood cell count at baseline >15×109/L;
4.The patient had previously received other anti-pd-1 antibody therapy or other immunotherapy targeting pd-1 / pd-L1,or received chemoradiotherapy;
5.Have a history of mental illness or psychiatric substance abuse;
6.Patients who had participated in clinical trials of other drugs within 4 weeks;
7.Patients with a serious risk to treating patients' safety or a concomitant disease that affects the completion of the study according to the researchers judgment;
8.Senior or uncontrolled virus injection: HIV, TP, hepatitis virus;
9.Other patients whom the medical practitioner considers inappropriate for inclusion.