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Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy (HCHTOG2603)

30. juli 2026 opdateret af: Henan Cancer Hospital

A Multicenter, Open-Label, Randomized Controlled Phase III Clinical Trial Comparing Surgery Versus Radical Chemoradiotherapy (Organ Preservation) in Patients With Thoracic Esophageal Squamous Cell Carcinoma Achieving cCR or cPR Following Neoadjuvant Immunochemotherapy

This is a Phase III, multicenter, open-label, randomized controlled trial. The study aims to compare organ preservation versus esophagectomy in patients with locally advanced, resectable thoracic esophageal squamous cell carcinoma (ESCC) who achieve a complete or partial clinical response (cCR/cPR) following neoadjuvant immunochemotherapy.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1044

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Henan
      • Zhengzhou, Henan, Kina, 450008
        • Rekruttering
        • Henan Cancer Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age 18-75 years, any sex.
  2. ECOG Performance Status 0-1.
  3. Histologically confirmed, previously untreated thoracic esophageal squamous cell carcinoma (ESCC).
  4. Clinical stage cT2N0M0, T3N0-2M0 (AJCC 8th Edition), assessed as resectable with a potential for R0 resection by endoscopic ultrasound (EUS), PET-CT, and contrast-enhanced CT. Patients with cervical lymph node metastasis may also be included if deemed suitable for three-field lymphadenectomy by a multidisciplinary team assessment.

  5. Adequate bone marrow, hepatic, and renal function:

    • Absolute neutrophil count ≥ 1.5 × 10⁹/L, Platelet count ≥ 100 × 10⁹/L, Hemoglobin ≥ 90 g/L.
    • Alanine aminotransferase / Aspartate aminotransferase ≤ 2.5 × Upper Limit of Normal, Total bilirubin ≤ 1.5 × Upper Limit of Normal.
    • Serum creatinine ≤ 1.5 × Upper Limit of Normal or Creatinine clearance ≥ 60 mL/min.
  6. Signed written informed consent form (ICF).

Exclusion Criteria:

  1. History of other malignancy within the past 5 years.
  2. Active autoimmune disease.
  3. Active Hepatitis B Virus (HBV) / Hepatitis C Virus (HCV) / Human Immunodeficiency Virus (HIV) infection.
  4. Severe cardiac or pulmonary insufficiency (Left Ventricular Ejection Fraction < 50%, Forced Expiratory Volume in 1 second < 1 L).
  5. Pregnancy or lactation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Organ Preservation with Radical Chemoradiotherapy
Patients achieving clinical complete or partial response (cCR/cPR) after neoadjuvant immunochemotherapy will receive definitive chemoradiotherapy for organ preservation. Radiotherapy (50.4 Gy/28 fractions, IMRT) with concurrent weekly chemotherapy (e.g., paclitaxel + cisplatin). Patients with ycCR after chemoradiotherapy will enter observation. Patients with residual disease will undergo salvage esophagectomy.
Medicin: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy
This is the standard induction therapy administered to all enrolled patients. It consists of the PD-1 inhibitor Toripalimab combined with Nab-paclitaxel
Kombinationsprodukt: Radiation with Concurrent Chemotherapy
Chemotherapy administered concurrently with radiotherapy
Eksperimentel: Immediate Esophagectomy
Patients achieving cCR/cPR after neoadjuvant immunochemotherapy will undergo immediate radical esophagectomy (McKeown or Ivor-Lewis procedure) with 2-field or 3-field lymph node dissection. Postoperative immunotherapy (up to 8 cycles) may be administered based on pathological findings (ypT≥1 or N+).
Medicin: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy
This is the standard induction therapy administered to all enrolled patients. It consists of the PD-1 inhibitor Toripalimab combined with Nab-paclitaxel
Procedure: Radical Esophagectomy
Standard surgical procedure with lymph node dissection
Aktiv komparator: Non-Responder Surgery
Patients with stable disease (cSD) or progressive disease (cPD) after neoadjuvant immunochemotherapy will undergo immediate radical esophagectomy, which is the standard of care for this subgroup. Postoperative treatment is determined by pathological findings.
Medicin: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy
This is the standard induction therapy administered to all enrolled patients. It consists of the PD-1 inhibitor Toripalimab combined with Nab-paclitaxel
Procedure: Radical Esophagectomy
Standard surgical procedure with lymph node dissection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
3-year Event-Free Survival (EFS) Rate
Tidsramme: 3 years after randomization/treatment initiation

Event-Free Survival is defined as the time from randomization (for responders) or from the start of neoadjuvant therapy (for the overall population) until the occurrence of any of the following events:

Local recurrence of esophageal cancer. Distant metastasis. Death from any cause
3 years after randomization/treatment initiation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Henan Cancer Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. juni 2026

Primær færdiggørelse (Anslået)

15. marts 2032

Studieafslutning (Anslået)

15. marts 2032

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-150

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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