Not Yet RecruitingPhase 2

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

China40 participantsStarted 2025-07-01

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria * The patient volunteers agreed to participate in the study, signed a consent form, exhibited good compliance, observed the follow-up procedures, and were willing and able to follow the protocol during the study. * Esophageal squamous cell carcinoma diagnosed by histopathology; * The patients have not received any systemic or local treatment for esophageal cancer in the past including radiotherapy, chemotherapy, surgery, etc; * The patients were evaluated as thoracic esophageal cancer through auxiliary examinations and clinical staging as T3N+M0 (according to AJCC 8th edition of esophageal cancer); * Expected to achieve R0 resection; * Age range: 18-75 years old, male or female not limited; * The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0-1； * The patients planned to undergo surgical treatment after completion of neoadjuvant therapy; * The patients had no surgical contraindications; * The main organ functions of patients were normal, including: a) blood routine examination (no blood components, cell growth factors, white blood boosting drugs, platelet boosting drugs, or anemia correcting drugs were allowed to be used within 14 days before the first use of the study drug); Neutrophil count ≥ 1.5 \* 10 \^ 9/L, platelet count ≥ 100 \* 10 \^ 9/L, hemoglobin ≥ 90g/L; b) Blood biochemistry test: Total bilirubin ≤ 1.5 \* ULN, ALT≤2.5\*ULN, AST≤2.5\*ULN, Serum creatinine ≤ 1.5 \* ULN, or creatinine clearance rate ≥ 50mL/min; c) Co…

What they're measuring

Pathological complete remission rate (pCR)

Timeframe: 12 weeks

Trial details

NCT IDNCT06965829

SponsorShanghai Chest Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-01

Contact for this trial

Guo xufeng

+8618930096739 shandagxf@126.com