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Suoliston matala-annos sädehoito plus immunokemoterapia raja-resektoitavan/ei-resektoitavan ruokatorven levyepiteelikarsinooman konversiohoitona (ILDR-03)

keskiviikko 30. syyskuuta 2026 päivittänyt: Chuangzhen Chen

Suoliston matala-annoksen sädehoidon ja Tislelizumabin sekä kemoterapian yhdistelmän teho ja turvallisuus rajatapauksen resektiokyvyn saavuttamisessa/ei-resektoitavassa ruokatorven levyepiteelisolukarsinoomassa

Esophageal cancer (EC) ranks among the leading malignant gastrointestinal tumors globally in terms of both incidence and mortality. Cases of EC in China account for over 50% of the global total, with squamous cell carcinoma being the primary pathological type. Locally advanced EC (LAEC), particularly cases where radical surgical resection is not feasible, exhibits high recurrence rates and low 5-year survival rates. However, studies have shown that patients with LAEC who undergo comprehensive treatment followed by surgery experience significantly prolonged survival and improved quality of life compared to those who do not receive surgical intervention.

Current conversion treatment regimens under investigation include: chemotherapy alone, chemoradiotherapy, immunotherapy combined with chemotherapy, and immunotherapy combined with chemoradiotherapy-each of these approaches has distinct advantages and limitations. Immunochemotherapy has emerged as a current research focus: it not only demonstrates significantly superior efficacy compared to chemotherapy alone but also exhibits lower cumulative toxicity than radiotherapy-combined conversion regimens, resulting in a more favorable overall benefit-risk ratio. As such, it represents the most promising conversion treatment strategy.

Retrospective and prospective clinical studies have shown that low-dose radiotherapy targeting the small intestine can enhance the anti-tumor response of immune checkpoint inhibitors (ICIs) in patients with advanced solid tumor, prolong their overall survival, and increase the incidence of the abscopal effect. Further mechanistic investigations have revealed that intestinal low-dose radiotherapy (ILDR) may augment the immune cancerous lethality by modulating the gut microbiota and their metabolic profiles.

Based on the findings from these preliminary studies, the current research plans to conduct a prospective phase II single-arm clinical trial to investigate the efficacy and safety of ILDR combined with immunochemotherapy as conversion therapy in patients with borderline resectable or unresectable esophageal squamous cell carcinoma (BR/UR ESCC). This research plans to enroll at least 39 evaluable cases or a total of 39 cases in two seperated stages, focusing on patients with thoracic BR/UR ESCC. Patients will receive a single fraction of ILDR with a mean dose of 1 Gy, concurrently with 3 cycles of albumin-bound paclitaxel (260 mg/m² on day 1), cisplatin (75 mg/m² on day 1), and tislelizumab (200 mg on day 1). The efficacy and safety of the treatment will be evaluated throughout the study.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

39

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

  • Kiina
    • Guangdong
      • Shantou, Guangdong, Kiina, 515031
        • Rekrytointi
        • Cancer Hospital, Shantou University Medical College
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 75 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  1. Patients voluntarily enroll in this study, sign an informed consent form, and demonstrate good compliance.

  2. Age ≥18 years and ≤75 years; both sexes are eligible.

  3. ECOG performance status score of 0-1.

  4. Pathologically confirmed esophageal squamous cell carcinoma (ESCC) prior to surgery.

  5. Thoracic esophageal cancer.

  6. Unresectable lesions, defined as: T4 stage; Borderline resectable T3 disease, in which imaging cannot exclude invasion of adjacent organs or structures, such as the trachea, bronchi, or aorta; T3 disease with supraclavicular lymph node metastasis; or clinically confirmed unresectable disease by the surgeon.

  7. No prior history of anti-tumor treatment, including chemotherapy, hormonal therapy, radiotherapy, or immunotherapy.

  8. Baseline laboratory requirements (within 7 days prior to enrollment):

    Hematology:

    1. Hb≥90 g/L (no transfusion within 14 days)
    2. NEUT ≥1.5×10⁹/L
    3. PLT ≥100×10⁹/L
    4. WBC≥3×10⁹/L

    Biochemistry:

    1. ALT and AST≤2.5×ULN
    2. TBIL≤1.5×ULN
    3. SCr≤1.5×ULN; or CrCl≥60 mL/min Coagulation: APTT, INR, and PT≤1.5×ULN Thyroid function: TSH≤ULN (if abnormal, FT3/FT4 levels should also be considered; eligible if FT3/FT4 are normal) Echocardiography: LVEF≥50%

  9. Female subjects need to agree to use contraception during the study and for 6 months post-study; serum pregnancy test negative within 7 days prior to enrollment; non-lactating. Male subjects must agree to use contraception during the study and for 6 months post-study.

  10. No psychological, familial, social, or geographical factors that may impair protocol adherence.

  11. Other parameters meet general clinical trial enrollment criteria.

  12. The subject or authorized representative has read, fully understands the patient information sheet, and signed the informed consent form.

Exclusion Criteria:

  1. Patients with distant metastases other than supraclavicular lymph node metastases.
  2. Presence or high risk of esophageal perforation.
  3. Patients with contraindications to radiotherapy or immune checkpoint inhibitor (ICI) therapy.
  4. Subjects with active, uncontrolled systemic bacterial, viral, or fungal infections despite optimal treatment.
  5. Respiratory depression, airway obstruction, or tissue hypoxia.
  6. Severe cardiac disease (i.e., NYHA functional class II or higher).
  7. Markedly abnormal liver or kidney function (i.e., indicators >3 times the upper limit of normal).
  8. Active hepatitis B, hepatitis C, HIV, or syphilis.
  9. Active brain disease or central nervous system/meningeal metastases with significant symptoms, or impaired decision-making capacity.
  10. Hypersensitivity to drugs included in the trial.
  11. Drug and/or alcohol abuse.
  12. Pregnant or lactating women.
  13. Concurrent participation in another therapeutic clinical trial.
  14. Major surgical procedure within 30 days prior to enrollment.
  15. Use of antibiotics, antifungals, antivirals, or antiparasitics within 4 weeks prior to registration.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei käytössä
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: ILDR plus immunochemotherapy plus surgery

1Gy/1F ILDR + albumin-bound paclitaxel (3 cycles of 260 mg/m² on day 1), cisplatin (3 cycles of 75 mg/m² on day 1), and tislelizumab (3 cycles of 200 mg on day 1) + surgery
Säteily: Intestinal Low Dose Radiotherapy-1Gy

1Gy ILDR will be administered to patients in a single fraction. The radiation treatment volume composes both the jejunum and ileum.

Lääke: PD-1/PD-L1 inhibitors

3 cycles of tislelizumab（200 mg D1 q3w）

Lääke: Chemotherapy

3 cycles of albumin-bound paclitaxel（260 mg/m2 D1 q3w）+ cisplatin（75 mg/m2 D1 q3w）

Menettely: Surgery

McKeown esophagectomy or laparoscopic-assisted McKeown esophagectomy is recommended, with either two-and-a-half-field lymphadenectomy or three-field lymph node dissection.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
1-Year Progression-Free Survival Rate (1y-PFSR)
Aikaikkuna: Up to 12 months after the initiation of treatment.

The 1y-PFSR is defined as the proportion of patients who remain alive without documented cancer progression 1 year after the initiation of treatment.
Up to 12 months after the initiation of treatment.

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Pathological Complete Response (pCR) Rate
Aikaikkuna: From postoperative day 0 up to 15 weeks postoperatively.

The proportion of patients who, following conversion therapy, exhibit no residual invasive cancer cells in either the primary tumor site or regional lymph nodes upon pathological evaluation of surgical resection specimens, expressed as a percentage of the total treated population.
From postoperative day 0 up to 15 weeks postoperatively.
Objective Response Rate (ORR)
Aikaikkuna: Baseline, every 6 weeks during conversion therapy, postoperation, every 4 months following the first postoperative assessment with a maximum duration of 12 months.

Proportion of patients achieving complete response (CR) or partial response (PR) (sustained ≥4 weeks) per RECIST v1.1 and iRECIST criteria.
Baseline, every 6 weeks during conversion therapy, postoperation, every 4 months following the first postoperative assessment with a maximum duration of 12 months.
Major Pathological Response (MPR) Rate
Aikaikkuna: From postoperative day 0 up to 15 weeks postoperatively.

MPR is defined as the proportion of patients with ≤10% residual viable tumor cells in surgical specimens following treatment. Pathological evaluation requires standardized sampling and separate assessment of lymph node metastases.
From postoperative day 0 up to 15 weeks postoperatively.
Disease Control Rate (DCR)
Aikaikkuna: Baseline, every 6 weeks during conversion therapy, postoperation, every 4 months following the first postoperative assessment with a maximum duration of 12 months.

DCR is defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) post-treatment, as measured by RECIST 1.1 and iRECIST criteria.
Baseline, every 6 weeks during conversion therapy, postoperation, every 4 months following the first postoperative assessment with a maximum duration of 12 months.
Adverse Event Incidence Rate
Aikaikkuna: Up to 12 months after surgery.

The proportion of patients experiencing adverse events of any grade (graded according to CTCAE 6.0, Common Terminology Criteria for Adverse Events, grades 1-5) during treatment.
Up to 12 months after surgery.
1-Year Overall Survival Rate (1y-OSR)
Aikaikkuna: Up to 12 months after the initiation of treatment.

The 1y-OSR is defined as the proportion of patients who have not experienced all-cause death at 12 months following the initiation of treatment.
Up to 12 months after the initiation of treatment.
Surgical Conversion Rate
Aikaikkuna: Up to 12 months after surgery.

Defined as the proportion of initially unresectable patients who are converted to resectable status following treatment.
Up to 12 months after surgery.
R0 Resection Rate
Aikaikkuna: From postoperative day 0 up to 15 weeks postoperatively.

Defined as the proportion of radical surgeries achieving microscopically negative margins (margin ≥1 mm).
From postoperative day 0 up to 15 weeks postoperatively.

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Peripheral Blood Immune Landscape
Aikaikkuna: Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.

Flow cytometry analysis is performed on peripheral blood samples.
Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.
Peripheral Blood Transcriptomics
Aikaikkuna: Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.

RNA sequencing is performed on peripheral blood samples.
Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.
Peripheral Blood Immune Receptor Repertoire
Aikaikkuna: Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.

TCR sequencing is performed on peripheral blood samples.
Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.
Serum Metabolomics
Aikaikkuna: Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.

The wide arrays of metabolites in peripheral blood samples are analyzed qualitatively and quantitatively.
Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.
Serum Cytokine Analysis
Aikaikkuna: Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.

The wide arrays of cytokines in peripheral blood samples are analyzed qualitatively and quantitatively.
Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.
Tissue Transcriptomics
Aikaikkuna: Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.

RNA sequencing is performed on tissue samples.
Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.
Tissue Immune Receptor Repertoire
Aikaikkuna: Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.

TCR sequencing is performed on tissue samples.
Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.
Tissue Immunohistochemistry
Aikaikkuna: Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.

Multi-marker fluorescent immunohistochemistry is performed on tissue samples.
Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.
Changes of Intestinal Flora
Aikaikkuna: Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.

Fecal samples are analyzed by metagenomics sequencing.
Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.
Fecal Metabolomics
Aikaikkuna: Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.

The wide arrays of metabolites in fecal samples are analyzed qualitatively and quantitatively.
Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection.

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Chuangzhen Chen

Yhteistyökumppanit

BeOne Medicines

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Maanantai 1. joulukuuta 2025

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Sunnuntai 4. tammikuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Keskiviikko 14. tammikuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 5. lokakuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 30. syyskuuta 2026

Viimeksi vahvistettu

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Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • SUMC-ILDR03

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