Toripalimab With Neoadjuvant Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

NCT ID: NCT04177797

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-20
• Study Completion Date: 2023-12-31

Brief Summary

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.

Detailed 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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Toripalimb

Single arm, non randomized, open label study.The patients will receive Toripalimb concurrently caboplatin and paclitaxel treatment.

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: DRUG

Two cycles of Toripalimab(240 mg administered as an intravenous infusion over 30 minutes per 3 weeks), concurrently paclitaxel(135 mg/m2) and carboplatin(AUC 5) administered as an intravenous infusion per 3 weeks.

Interventions

Toripalimab

Two cycles of Toripalimab(240 mg administered as an intravenous infusion over 30 minutes per 3 weeks), concurrently paclitaxel(135 mg/m2) and carboplatin(AUC 5) administered as an intravenous infusion per 3 weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Yongtao Han

Director,Head of Thoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, China

Countries

China

References

He W, Leng X, Mao T, Luo X, Zhou L, Yan J, Peng L, Fang Q, Liu G, Wei X, Wang K, Wang C, Zhang S, Zhang X, Shen X, Huang D, Yi H, Bei T, She X, Xiao W, Han Y. Toripalimab Plus Paclitaxel and Carboplatin as Neoadjuvant Therapy in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma. Oncologist. 2022 Feb 3;27(1):e18-e28. doi: 10.1093/oncolo/oyab011.

Reference Type: DERIVED

PMID: 35305102 (View on PubMed)

Other Identifiers

SCCH-TS2001

Identifier Type: -

Identifier Source: org_study_id