Selected Chemotherapy Combined Immunotherapy Treated High Risk Patient After NCRT in Resected Locally Advanced ESCC

NCT05189730 | Active Not Recruiting Phase 2

• 1 other identifier: SCCH-TS2107
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Tislelizumab combined with chemotherapy sequential neoadjuvant therapy for non-cCR patients after neoadjuvant chemoradiotherapy in locally advanced ESCC. And then the patients would receive surgery and adjuvant therapy according to the postoperative pathological results. It is expected that through this study, some high-risk patients could obtain better efficacy and prolong patient survival. At same time, low risk patients could avoid increasing perioperative complications and surgical risks, so that more patients could benefit from neoadjuvant treatment. The investigators aimed to explore a more accurate comprehensive treatment mode for patients with esophageal squamous cell carcinoma, and provide a certain scientific basis for the formulation of esophageal cancer diagnosis and treatment norms in China.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

neoadjuvant treatment; immunotherapy; chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

• Complete pathologic response rate

  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"

  3 months

• Incidence of adverse events

  Number of participants with treatment-related adverse events as assessed by Number of participants with treatment-related adverse events as assessed by treatment-related adverse events assessed by CTCAE v4.0

  6 months

Secondary Outcomes (6)

• Clinical Complete Remission

  3 months

• Major Pathological Remission rate

  3 months

• Objective Remission Rate

  3 months

• Rate of R0 resection

  3 months

• Events Free Survival

  Through study completion, an average of 1 year.

Study Arms (1)

Total neoadjuvant therapy

EXPERIMENTAL

The patients would receive neoadjuvant chemoradiotherapy treatment firstly. And then evaluated efficacy according to RECIST 1.1. If patients with cCR would receive surgery treatment after 4-6 weeks. After surgery, patients with pCR would always perform surveillance and patients with non-pCR would receive immunotherapy alone treatment. If patients evaluated as PD, they would receive new treatment regimen after MDT discussed. Other patients with PR and SD would receive 2 cycles of neoadjuvant immunochemotherapy. And then, Efficacy of immunochemotherapy would be evaluated according to RECIST 1.1. For patients suitable for surgery, surgery should be performed after 4-6 weeks of immunotherapy. After surgery, the patients with R0 resection would divided into two groups, if patients with pCR would always perform surveillance and patients with non-pCR would receive immunotherapy treatment. Other patients without R0 resection would receive new treatment regimen after MDT discussed.

Drug: Tirelizumab; Drug: Paclitaxel; Drug: Carboplatin; Radiation: Neoadiuvant radiotherapy

Interventions

Tirelizumab DRUG

Two cycles of Tirelizumab (200mg administered as an intravenous infusion over 30 minutes per 3 weeks), D1.

Total neoadjuvant therapy

Paclitaxel DRUG

Two cycles of paclitaxel (135mg/m2 administered as an intravenous infusion per 3 weeks), D1.

Total neoadjuvant therapy

Carboplatin DRUG

Two cycles of carboplatin(AUC=5 administered as an intravenous infusion per 3 weeks) D1.

Total neoadjuvant therapy

Neoadiuvant radiotherapy RADIATION

Simultaneous radiotherapy would be consecutively performed for 4 weeks with the total dose of 40Gy (40Gy/ 4W /20F), D1.

Total neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed ESCC；
• Clinical stage T2N0-1M0, T3N0M0, T3N1M0, T1-3N2M0（II-III) (AJCC 8 TNM classif tion);
• Locally advanced ESCC that can be treated surgically evaluated before treatment;
• At least one measurable lesion in accordance with RECIST 1.1;
• Have a performance status of 0 or 1 on the ECOG Performance Scale;
• Expected survival time is greater than 6 months;
• 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;
• Female subjects of childbearing potential have a negative pregnancy test and must agree to take effective contraceptive measures during the study period and within 3 months after the last dose;
• Be willing and able to provide written informed consent/assent for the trial.

You may not qualify if:

• The patient have received radiotherapy, chemotherapy, hormone therapy, surgery, or molecular-targeted therapy;
• Confirmed patients with distant metastasis by CT imaging;
• The subject has previous or co-existing other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• The subject had previously received other anti-pd-1 antibody therapy or other immunotherapy targeting pd-1 / pd-L1;
• Patients with active autoimmune disease or documented autoimmune disease or symptoms requiring systemic hormone therapy or anti-autoimmune drug therapy;
• Patients with immunodeficiency or who were still receiving systemic steroid hormone therapy (prednisone \> 10 mg/ day or other equivalent drugs) or other forms of immunosuppressive therapy 7 days prior to the first dose of neoadjuvant therapy in this study;
• Clinical ascites or pleural effusion requiring therapeutic puncture or drainage;
• The subject with uncontrol cardiac clinical symptoms or diseases, such as :(1) nyha class 2 or more heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant ventricular or ventricular arrhythmias requiring treatment or intervention;
• Abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\> 2G /L), bleeding tendency or receiving thrombolytic or anticoagulant treatment;
• The subject is present (within 3 months) with esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension and other gastrointestinal diseases, or with active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator;
• Past or present severe bleeding (bleeding \>30 ml within 3 months), hemoptysis (fresh blood \>5 ml within 4 weeks) or thromboembolism events (including stroke events and/or TRANSIENT ischemic attack) within 12 months;
• Patients with active infection who still required systemic treatment 7 days before the first dose of neoadjuvant therapy in this study;
• Patients with past or present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severely impaired lung function, etc;
• Senior or uncontrolled virus injection: HIV, TP, hepatitis virus;
• Senior or uncontrolled virus injection: HIV, TP, hepatitis virus;

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• He W, Wang C, Wu L, Wan G, Li B, Han Y, Li H, Leng X, Du K, Chen H, Wang Q, Peng L. Tislelizumab Plus Chemotherapy Sequential Neoadjuvant Therapy for Non-cCR Patients After Neoadjuvant Chemoradiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma (ETNT): An Exploratory Study. Front Immunol. 2022 Jun 2;13:853922. doi: 10.3389/fimmu.2022.853922. eCollection 2022.

  PMID: 35720312 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Thoracic Surgery

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: January 12, 2022
• Study Start: July 1, 2021
• Primary Completion: January 31, 2025
• Study Completion (Estimated): January 31, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

CN (1)