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Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

26 aprile 2026 aggiornato da: Second Affiliated Hospital of Zunyi Medical University

Efficacy and Safety of Induction Chemo-Immunotherapy Followed by Radiotherapy vs Concurrent Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Randomized, Two-Arm, Phase II Study

This is a prospective, randomized, phase II clinical study in patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC). Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups. The experimental group will receive 3 cycles of induction therapy with PD-1 antibody plus chemotherapy, followed by radiotherapy, and then maintenance therapy with PD-1 antibody monotherapy. The control group will receive concurrent chemoradiotherapy, followed by maintenance therapy with PD-1 antibody monotherapy. The primary endpoints are the complete response (CR) rate at 3 months after radiotherapy (assessed by investigators) and the 1-year progression-free survival (PFS) rate. Secondary endpoints include overall survival (OS), progression-free survival (PFS), duration of response, objective response rate (ORR), local-regional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), quality of life, and safety profile.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a prospective, randomized, two-arm, phase II clinical trial investigating induction chemo-immunotherapy followed by sequential radiotherapy versus concurrent chemo-immunotherapy plus radiotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC).

Current standard of care for unresectable locally advanced ESCC is definitive concurrent chemoradiotherapy. However, outcomes remain suboptimal, with high rates of local recurrence and distant metastasis. The addition of PD-1 inhibitors to concurrent chemoradiotherapy has shown promising activity in recent studies, but optimal sequencing and integration of immunotherapy with radiotherapy are still under investigation.

This trial is designed to evaluate whether an induction strategy with chemo-immunotherapy followed by radiotherapy can improve response rates and long-term survival compared to the standard concurrent approach. Patients will be randomized to receive either:

  • Experimental arm: Three cycles of induction chemo-immunotherapy, followed by definitive thoracic radiotherapy, then maintenance immunotherapy for up to one year.
  • Control arm: Concurrent chemo-immunotherapy plus definitive thoracic radiotherapy, followed by maintenance immunotherapy for up to one year.

The primary objective is to compare the efficacy of the two regimens in terms of complete response and progression-free survival. Safety, tolerability, and quality of life will also be assessed to support the risk-benefit profile of each strategy.

Tipo di studio

Interventistico

Iscrizione (Stimato)

92

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Jian-Guo Zhou, PhD
  • Numero di telefono: +86-851-18212154044
  • Email: jsdxzl@126.com

Luoghi di studio

  • Cina
    • Guizhou
      • Zunyi, Guizhou, Cina, 563000
        • Reclutamento
        • The Second Affiliated Hospital of Zunyi Medical University, Xinpu New District, Honghuagang District, Zunyi City, Guizhou Province
        • Contatto:
          • lei zhou, Master
          • Numero di telefono: +86-851-18212154044
          • Email: jsdxzl@126.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Histologically or cytologically confirmed unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate organ function (bone marrow, liver, renal, cardiac) within 2 weeks prior to randomization
  • Measurable or evaluable disease per RECIST 1.1
  • Willing to provide written informed consent

Exclusion Criteria:

  • Previous radiotherapy to the chest or previous systemic chemotherapy for ESCC
  • History of other malignancies within the last 5 years (except cured basal cell carcinoma or cervical carcinoma in situ)
  • Severe comorbidities (uncontrolled hypertension, NYHA class III-IV heart failure, active infection, etc.)
  • Known hypersensitivity to any study drugs (paclitaxel, cisplatin/carboplatin, PD-1 antibody)
  • Pregnant or lactating women
  • Participation in another clinical trial within 30 days prior to randomization

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Experimental Group: Chemo-Immunotherapy Induction + Radiotherapy + PD-1 Maintenance
Patients receive 3 cycles of PD-1 antibody plus chemotherapy induction therapy, followed by thoracic radiotherapy (50.4Gy in 28 fractions), then PD-1 antibody maintenance therapy (200mg IV q3w, up to 1 year).
Droga: Paclitaxel plus Cisplatin or Carboplatin (Induction Chemotherapy)
Paclitaxel 150-175 mg/m² combined with cisplatin 75 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously every 3 weeks for 3 cycles, concurrent with PD-1 antibody induction therapy for unresectable stage III-IVA esophageal squamous cell carcinoma.
Comparatore attivo: Control Group: Concurrent Chemoradiotherapy + PD-1 Maintenance
Patients receive weekly paclitaxel + cisplatin/carboplatin concurrent with thoracic radiotherapy (50.4Gy in 28 fractions), then PD-1 antibody maintenance therapy (200mg IV q3w, up to 1 year).
Droga: Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy)
Paclitaxel 50 mg/m² combined with cisplatin 25 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously once weekly for 5 cycles, concurrent with thoracic radiotherapy (50.4Gy in 28 fractions) for unresectable stage III-IVA esophageal squamous cell carcinoma.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Complete Response (CR) Rate at 3 Months After Radiotherapy (Investigator-Assessed)
Lasso di tempo: 3 months after completion of radiotherapy
Proportion of patients achieving complete response (CR) per RECIST 1.1, assessed by investigators at 3 months after completion of radiotherapy
3 months after completion of radiotherapy
1-Year Progression-Free Survival (PFS) Rate
Lasso di tempo: 1 year after randomization
Proportion of patients alive and without disease progression at 1 year after randomization
1 year after randomization

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: Up to 3 years after randomization
Time from randomization to death from any cause
Up to 3 years after randomization
Progression-Free Survival (PFS)
Lasso di tempo: Up to 3 years after randomization
Time from randomization to first documented disease progression or death from any cause, whichever occurs first
Up to 3 years after randomization
Duration of Response (DOR)
Lasso di tempo: Up to 3 years after randomization
Time from first documentation of objective response (CR/PR) to first documented disease progression or death
Up to 3 years after randomization
Objective Response Rate (ORR)
Lasso di tempo: Up to 3 years after randomization
Proportion of patients achieving CR or partial response (PR) per RECIST 1.1
Up to 3 years after randomization
Local Regional Failure-Free Survival (LRFS)
Lasso di tempo: Up to 3 years after randomization
Time from randomization to first local or regional recurrence or death
Up to 3 years after randomization
Distant Metastasis-Free Survival (DMFS)
Lasso di tempo: Up to 3 years after randomization
Time from randomization to first distant metastasis or death
Up to 3 years after randomization
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Lasso di tempo: From first study treatment to 30 days after last treatment
Incidence and severity of TEAEs (graded per CTCAE 5.0) during treatment and follow-up
From first study treatment to 30 days after last treatment
EORTC QLQ-OES18 Symptom Score Change
Lasso di tempo: Baseline, 3 months, 6 months, 12 months after radiotherapy
Change in esophageal cancer-specific symptom score as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Oesophageal 18 (EORTC QLQ-OES18) from baseline to post-treatment follow-ups. The scale ranges from 0 to 100, with higher scores indicating more severe symptoms and worse quality of life.
Baseline, 3 months, 6 months, 12 months after radiotherapy
EORTC QLQ-C30 Quality of Life Score Change
Lasso di tempo: Baseline, 3 months, 6 months, 12 months after radiotherapy.
Change in quality of life score as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) from baseline to post-treatment follow-ups. The scale ranges from 0 to 100, with higher scores indicating better quality of life.
Baseline, 3 months, 6 months, 12 months after radiotherapy.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Second Affiliated Hospital of Zunyi Medical University

Investigatori

  • Investigatore principale: Lei Zhou, Master, The Second Affiliated Hospital of Zunyi Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2026

Completamento primario (Stimato)

1 gennaio 2028

Completamento dello studio (Stimato)

30 giugno 2028

Date di iscrizione allo studio

Primo inviato

28 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 aprile 2026

Primo Inserito (Effettivo)

30 aprile 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 aprile 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KYLL-2025-143

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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