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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 bijgewerkt door: 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).

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

33

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

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

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pathologic Complete Response (pCR) Rate
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Major Pathologic Response (MPR) Rate
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

10 september 2026

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

31 december 2029

Studieregistratiedata

Eerst ingediend

28 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 september 2026

Eerst geplaatst (Werkelijk)

9 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 september 2026

Laatste update ingediend die voldeed aan QC-criteria

8 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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