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

NCT06965829 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-11

No results posted yet for this study

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

Conditions

  • Esophageal Cancer Stage III

Interventions

DRUG

Tislelizumab

Neoadjuvant immunotherapy (tislelizumab 200 mg d1, q3w × 2 cycles)

DRUG

Carboplatin and Paclitaxel and Radiation Therapy

Neoadjuvant 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)

Sponsors & Collaborators

  • Shanghai Chest Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2028-07-01
Completion
2028-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06965829 on ClinicalTrials.gov