The Effect of Neoadjuvant Chemoimmnotherapy Combined With Node Sparing Radiotherapy for cT3N+ EC

Phase 2

Not yet recruiting

• Conditions: Esophageal Cancer Stage III
• Interventions: Drug: Tislelizumab; Drug: Carboplatin and Paclitaxel and Radiation Therapy

• Registration Number: NCT06965829
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

Background The promising therapeutic outcomes of neoadjuvant chemoimmnotherapy in the treatment of locally advanced esophageal squamous cell carcinoma (ESCC) have been confirmed by several phase II clinical trials and have been widely demonstrated in clinical work. However, in clinical practice, there have been cases of obvious tumor invasion, such as poor tumor regression after cT3 stage receiving NCIT, which reflects the insufficient effectiveness of NCIT for large T type tumors. It may be necessary to add radiotherapy to further improve the local control effect of tumors, but also means higher toxicity reactions. Node sparing radiotherapy can reduce it and enhance the effect of NCIT, which has been applied to the treatment of locally advanced rectal cancer. The aim of this study was to analyze the safety and efficacy of neoadjuvant chemoimmnotherapy combined with node sparing radiotherapy for clinical T3N+ locally advanced esophageal cancer (CINSREC Study).

Methods Forty eligible patients with pathologically confirmed thoracic ESCC of clinical T3N1-3M0 stage were allocated to receive neoadjuvant immunotherapy (tislelizumab 200 mg d1, q3w × 2 cycles) plus chemotherapy (nad-paclitaxel 260 mg/m2 d1 + carboplatin AUC = 5 d1, q3w × 2 cycles) and node sparing radiotherapy (41.4Gy/23 times: 1.8Gy d1-5, qw × 4-5 cycles) treatment. The primary endpoint of this study is pathological complete remission rate (pCR). The secondary endpoints include major pathological response rate, 2-year DFS in pCR patients, adverse events, and overall survival.

Discussion This protocol was reviewed and approved by the Ethics Committee of Shanghai Chest Hospital. This is the first prospective clinical trial to investigate the safety and efficacy of neoadjuvant chemoimmnotherapy combined with node sparing radiotherapy for clinical T3N+ locally advanced esophageal cancer. We hypothesize that this therapy could be a promising therapeutic strategy that can provide better prognosis and safety

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-04-25
• Study First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-02
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-11
• Study Start: 2025-07-01
• Primary Completion: 2028-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NCIT combined with node sparing radiotherapy for clinical T3N+ locally advanced esophageal cancer	Tislelizumab	-
NCIT combined with node sparing radiotherapy for clinical T3N+ locally advanced esophageal cancer	Carboplatin and Paclitaxel and Radiation Therapy	-

Primary Outcome Measures

Name	Time	Method
Pathological complete remission rate (pCR)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Major Pathological Response Rate (MPR)	12 weeks
Overall survival (OS)	2 years
Disease free survival (DFS)	2 years
Adverse events	12 weeks

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China