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장 저선량 방사선 치료와 면역화학요법 병용을 통한 경계 절제 가능/절제 불가능 식도 편평세포암의 전환 치료 (ILDR-03)

2026년 9월 30일 업데이트: Chuangzhen Chen

경계선 절제 가능/절제 불가능 식도 편평세포암의 전환을 위한 장 저선량 방사선 치료 플러스 티슬리주맙 및 화학요법 병용 요법의 유효성과 안전성

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

39

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Guangdong
      • Shantou, Guangdong, 중국, 515031
        • 모병
        • Cancer Hospital, Shantou University Medical College
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
방사능: 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.

의약품: PD-1/PD-L1 inhibitors

3 cycles of tislelizumab（200 mg D1 q3w）

의약품: Chemotherapy

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

절차: Surgery

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
1-Year Progression-Free Survival Rate (1y-PFSR)
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Pathological Complete Response (pCR) Rate
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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.

기타 결과 측정

결과 측정
측정값 설명
기간
Peripheral Blood Immune Landscape
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Chuangzhen Chen

협력자

BeOne Medicines

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 12월 5일

기본 완료 (추정된)

2029년 10월 30일

연구 완료 (추정된)

2029년 10월 30일

연구 등록 날짜

최초 제출

2025년 12월 1일

QC 기준을 충족하는 최초 제출

2026년 1월 4일

처음 게시됨 (실제)

2026년 1월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 30일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SUMC-ILDR03

개별 참가자 데이터(IPD) 계획

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아니요

약물 및 장치 정보, 연구 문서

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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