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Node-Sparing Short-Course Radiotherapy (25 Gy/5 Fractions) Combined With Chemoimmunotherapy as Neoadjuvant Treatment for Locally Advanced Esophageal Squamous Cell Carcinoma:A Prospective Single-Arm, Phase II Study (NeoSCRTIC-01)

8. September 2026 aktualisiert von: HONGYING_LIAO, Sixth Affiliated Hospital, Sun Yat-sen University
This prospective, single-arm phase II study will evaluate the efficacy and safety of lymphatic-drainage-sparing short-course radiotherapy combined with camrelizumab and nab-paclitaxel/carboplatin as neoadjuvant treatment for patients with resectable, locally advanced thoracic esophageal squamous cell carcinoma. Participants will receive three 3-week cycles of camrelizumab plus chemotherapy, with 25 Gy in 5 fractions of short-course radiotherapy delivered to the primary tumor and radiographically positive lymph nodes while elective lymphatic drainage regions are spared. Definitive McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant therapy. The primary endpoint is pathologic complete response (ypT0N0).

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

The study is designed as a Simon optimal two-stage, single-arm phase II trial. The target sample size is 33 participants, allowing for approximately 10% attrition. In stage 1, 15 participants will be enrolled; if at least 4 achieve pathologic complete response, enrollment will proceed to stage 2. A further 15 evaluable participants will then be enrolled. The protocol considers the regimen promising if at least 15 of 30 evaluable participants achieve pathologic complete response.

Eligible participants are treatment-naive adults aged 18-75 years with PET-CT and pathologically confirmed thoracic esophageal squamous cell carcinoma, clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (AJCC 9th edition), ECOG performance status 0-1, measurable disease by RECIST v1.1, and disease considered amenable to R0 resection.

Neoadjuvant treatment consists of camrelizumab 200 mg intravenously on Day 1 every 3 weeks plus nab-paclitaxel 260 mg/m² on Day 1 and carboplatin AUC 5 on Day 1 for three cycles. Short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle, targeting only the primary tumor and positive lymph nodes and sparing elective lymphatic drainage regions. Tumor imaging is performed after the second cycle and before surgery. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant therapy when hematologic and organ function have recovered. Postoperative survival follow-up is planned every 3 months for 3 years.

Studientyp

Interventionell

Einschreibung (Geschätzt)

33

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Hongying Liao MD, Professor / Chief Physician, MD and PhD
  • Telefonnummer: +86-020-35919121
  • E-Mail: liaohy2@mail.sysu.edu.cn

Studienorte

    • Guangdong
      • Guanzhou, Guangdong, China, 510655
        • Rekrutierung
        • The Sixth Affiliated Hospital, Sun Yat-sen University
        • Kontakt:
          • Hongying Liao MD, Professor / Chief Physician, MD and PhD
          • Telefonnummer: +86-020-35919121
          • E-Mail: liaohy2@mail.sysu.edu.cn
        • Kontakt:
        • Hauptermittler:
          • Hongying Liao, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Written informed consent before enrollment.
  • Age 18 to 75 years, any sex.
  • Treatment-naive esophageal squamous cell carcinoma confirmed by pathology and PET-CT.
  • Clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (stage II/III according to the AJCC 9th edition).
  • Disease assessed as amenable to R0 surgical resection before treatment.
  • At least one measurable lesion according to RECIST v1.1.
  • ECOG performance status 0-1.
  • Adequate organ function: absolute neutrophil count ≥1,500/mm³; platelets ≥100,000/mm³; hemoglobin ≥9 g/dL; serum creatinine ≤1.5 mg/dL and/or creatinine clearance ≥60 mL/min; bilirubin ≤1.5×ULN; AST and ALT ≤1.5×ULN; no blood components or hematopoietic growth factors within 14 days.
  • For women of childbearing potential: medically accepted contraception during treatment and for 3 months afterward; negative serum or urine HCG within 7 days before enrollment; not breastfeeding.
  • For men who are not surgically sterile: agreement to use medically accepted contraception with their partner during treatment and for 3 months afterward.
  • Willingness to participate and comply with safety and survival follow-up.

Exclusion Criteria:

  • Prior radiotherapy, chemotherapy, prolonged/high-dose corticosteroid therapy, surgery, or molecular targeted therapy.
  • Previous or concurrent other malignancy.
  • Prior PD-1/PD-L1 therapy; known allergy to macromolecular protein preparations or any component of PD-1 therapy.
  • Active autoimmune disease or relevant autoimmune disease history as specified in the protocol.
  • Immunosuppressive agents for immunosuppression within 2 weeks before enrollment.
  • Symptomatic pleural or peritoneal effusion requiring therapeutic puncture or drainage.
  • Poorly controlled clinically significant cardiac disease as specified in the protocol.
  • Abnormal coagulation with bleeding tendency or thrombolytic/anticoagulant therapy.
  • Recent gastrointestinal conditions associated with bleeding or perforation risk.
  • Severe bleeding within 3 months, hemoptysis within 4 weeks, or thromboembolic event within 12 months according to protocol thresholds.
  • Active infection or unexplained fever >38.5°C during screening or before first dose.
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before study treatment.
  • History/current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe pulmonary dysfunction.
  • Congenital/acquired immunodeficiency including HIV infection, or active hepatitis outside protocol-defined limits.
  • Participation in another clinical study or completion of a previous clinical study within 1 month; anticipated need for other systemic anticancer therapy.
  • Live vaccine within 4 weeks before study treatment or anticipated during the study.
  • Known history of psychotropic drug abuse, alcohol abuse, or illicit drug abuse.
  • Unable or unwilling to bear self-paid portions of study-related examinations or treatment.
  • Any other condition considered by the investigator to compromise participant safety, study completion, or data/sample collection.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin
Participants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin. Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment.

Participants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin. Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment.

Drug: Camrelizumab Camrelizumab 200 mg intravenously on Day 1 of each 3-week cycle for 3 cycles.

Drug: Nab-paclitaxel Nab-paclitaxel 260 mg/m² intravenously on Day 1 of each 3-week cycle for 3 cycles.

Drug: Carboplatin Carboplatin AUC 5 intravenously on Day 1 of each 3-week cycle for 3 cycles.

Radiation: Short-course radiotherapy 25 Gy in 5 fractions over 5 days, delivered to the primary tumor and radiographically positive lymph nodes while elective lymphatic drainage regions are spared.

Procedure: McKeown esophagectomy McKeown esophagectomy with thoracoabdominal two-field lymph node dissection, planned 4-6 weeks after completion of neoadjuvant therapy (maximum extension of 2 additional

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pathologic Complete Response (pCR) Rate
Zeitfenster: At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
Percentage of participants undergoing definitive surgery who have no residual viable tumor in the resected primary tumor and regional lymph nodes, defined in the protocol as ypT0N0.
At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Major Pathologic Response (MPR) Rate
Zeitfenster: At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
Major pathologic response (MPR) is defined as ≤10% residual viable tumor cells in the primary esophageal tumor resection specimen, regardless of lymph node status, as pre-specified in study protocol. The percentage of participants achieving this protocol-defined MPR criterion in post-neoadjuvant surgical resection specimen will be calculated.
At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
Objective Response Rate (ORR)
Zeitfenster: From baseline to the preoperative tumor assessment, approximately 9-15 weeks after initiation of neoadjuvant therapy.
Percentage of participants with complete response or partial response according to RECIST v1.1 based on protocol-specified imaging assessments.
From baseline to the preoperative tumor assessment, approximately 9-15 weeks after initiation of neoadjuvant therapy.
R0 Resection Rate
Zeitfenster: Upon completion of final postoperative pathological assessment, expected within 7 days post-operatively
Percentage of participants undergoing esophagectomy with microscopically negative resection margins.
Upon completion of final postoperative pathological assessment, expected within 7 days post-operatively
Disease-Free Survival (DFS) Rate
Zeitfenster: 1 year and 3 years after surgery.
Disease-free survival rate at 1 and 3 years.
1 year and 3 years after surgery.
Overall Survival (OS) Rate
Zeitfenster: 1 year and 3 years after surgery.
Overall survival rate at the specified time points. Survival will be estimated using the Kaplan-Meier method.
1 year and 3 years after surgery.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

10. September 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2026

Studienabschluss (Geschätzt)

31. Dezember 2029

Studienanmeldedaten

Zuerst eingereicht

28. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. September 2026

Zuerst gepostet (Tatsächlich)

9. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. September 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

Individual participant data sharing is not currently planned. De-identified data may be considered upon reasonable request and subject to institutional and ethics requirements.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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