Clinical trial · Interventional
Toripalimab With Neoadjuvant Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
A Single Arm Trial of Toripalimab With Neoadjuvant Carboplatin and Paclitaxel for Locally Advanced Esophageal Squamous Cell Carcinoma
NCT04177797CI-TRIAL-00056429unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Toripalimb
- description
- Single arm, non randomized, open label study.The patients will receive Toripalimb concurrently caboplatin and paclitaxel treatment.
- interventionNames
- Drug: Toripalimab
Primary outcomes (1)
- measure
- Complete pathologic response rate
- timeFrame
- 3 months
- description
- Definition of complete pathologic response is "no cancer cell, including lympho nodes" which corresponds with tumor regression score 0. Definition of pathologic response is as follows. Tumor regression score Grade 0 and 1 will be defined as "responder" and 2 and 3 will be considered as "non-responders"
Secondary outcomes (3)
- measure
- Disease control rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHe 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. PMID 35305102