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Neoadjuvant Anlotinib and Epirubicin for T4 Sinonasal Adenoid Cystic Carcinoma (NAET4-SNACC)

2026년 5월 23일 업데이트: Quan Liu, Eye & ENT Hospital of Fudan University

Neoadjuvant Anlotinib Combined With Epirubicin for T4 Stage Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Trial

T4 stage sinonasal adenoid cystic carcinoma (SNACC) is a rare but aggressive cancer in the nasal cavity and sinuses. These tumors often invade the skull base, eye socket, or brain covering (dura), making complete surgical removal difficult and carrying a high risk of recurrence even after surgery and radiation. The goal of this study is to test whether a new combination of drugs given before surgery - anlotinib (a targeted therapy) plus epirubicin (a chemotherapy drug) - can improve outcomes for patients with T4 SNACC.

This is a prospective, multicenter, single-arm, phase II clinical trial. Eligible participants will receive 2 cycles of neoadjuvant treatment (anlotinib orally for 2 weeks on/1 week off, plus epirubicin intravenously on day 1 of each 3-week cycle). After completing neoadjuvant therapy, participants will undergo surgery to remove the tumor, followed by postoperative radiotherapy. The main question the study tries to answer is whether this approach increases the 3-year progression-free survival (PFS) rate compared to the historical rate of about 70% with standard treatment (surgery plus radiotherapy alone). Secondary questions include how many tumors shrink after neoadjuvant treatment, how many operations achieve complete removal with negative margins, major pathological response rates, overall survival, safety, quality of life, and the chance of avoiding disfiguring surgeries (such as removal of the eye or part of the skull). The study will enroll about 76 participants from 5 top medical centers in China. If positive, this study may establish a new standard of care for T4 SNACC.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

Sinonasal adenoid cystic carcinoma (SNACC) is a rare cancer. T4 stage tumors often invade the skull base, orbit, or dura, making complete surgical removal difficult. Even with surgery and radiotherapy, the 3-year progression-free survival (PFS) is only about 70%, and extensive resection may cause disfigurement or loss of function.

This is a prospective, multicenter, single-arm, phase II trial. Eligible patients will receive 2 cycles of neoadjuvant therapy (anlotinib 10 mg orally on days 1-14 plus epirubicin 70 mg/m² IV on day 1, 21-day cycle). After neoadjuvant treatment, patients undergo surgery followed by postoperative radiotherapy.

The primary endpoint is 3-year PFS rate, compared with the historical rate of 70%. Secondary endpoints include objective response rate, R0 resection rate, major pathological response, overall survival, safety, quality of life, and organ preservation rate. Exploratory endpoints include biomarkers, ctDNA dynamics, and organoid drug sensitivity.

Target sample size is 76 patients from 5 Chinese centers. The study has been approved by the Institutional Review Board of Eye & ENT Hospital of Fudan University (approval number 2026069-1). Written informed consent will be obtained from all participants.

연구 유형

중재적

등록 (추정된)

76

단계

  • 2 단계

연락처 및 위치

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

연구 연락처

  • 이름: Quan Liu, MD
  • 전화번호: +86 15001959681
  • 이메일: liuqent@163.com

연구 연락처 백업

연구 장소

  • 중국
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100053
        • Xuanwu Hospital, Capital Medical University
        • 연락하다:
          • Zhenlin Wang, MD
          • 전화번호: 010-83198899 wzl1812@163.com
          • 이메일: wzl1812@163.com
    • Guangdong
      • Guangzhou, Guangdong, 중국, 510630
        • The Third Affiliated Hospital of Sun Yat-Sen University
        • 연락하다:
    • Shandong
      • Qingdao, Shandong, 중국, 266000
        • The Affiliated Hospital of Qingdao University
        • 연락하다:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 중국, 200031
        • Eye & ENT Hospital of Fudan University
        • 연락하다:
      • Shanghai, Shanghai Municipality, 중국, 200030

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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Age 18 to 75 years, any sex.
  • Histopathologically confirmed sinonasal adenoid cystic carcinoma (any subtype).
  • Stage T4a or T4b according to AJCC 8th edition. If lymph node metastasis is present, it must be surgically resectable. If distant metastasis is present, metastatic lesions must be stable.
  • Multidisciplinary team (MDT) assessment confirms that the tumor is technically resectable but with high risk (invasion of skull base, orbit, dura, etc.).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Adequate bone marrow, liver, kidney, and cardiac function: absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L; ALT/AST ≤2.5×upper limit of normal (ULN), total bilirubin ≤1.5×ULN; creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min; left ventricular ejection fraction (LVEF) ≥50%.
  • Willing to participate and able to provide written informed consent (including for clinical treatment and translational research).

Exclusion Criteria:

  • Prior radiotherapy to the head and neck region.
  • Prior anthracycline therapy with cumulative dose ≥300 mg/m².
  • Known hypersensitivity to any component of anlotinib or epirubicin.
  • Uncontrolled hypertension, severe cardiovascular disease, or active infection.
  • Pregnant or breastfeeding women.
  • Any medical or psychosocial condition that, in the investigator's judgment, may interfere with study compliance or conduct.

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: Neoadjuvant Anlotinib + Epirubicin
Participants receive neoadjuvant therapy for 2 cycles (each cycle is 21 days). Anlotinib 10 mg orally once daily on days 1-14 (2 weeks on, 1 week off). Epirubicin 70 mg/m² intravenous infusion on day 1 of each cycle. After completion of neoadjuvant therapy, participants undergo radical surgery followed by postoperative radiotherapy as per protocol.
의약품: Anlotinib + Epirubicin
Anlotinib 10 mg orally once daily on days 1-14 of each 21-day cycle (2 weeks on, 1 week off) for 2 cycles.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
3-Year Progression-Free Survival
기간: From enrollment to 3 years post-enrollment (assessed every 3 months for the first 2 years, then every 6 months) or until progression or death
Progression-free survival (PFS) is defined as the time from enrollment to the first documentation of disease progression (local recurrence, regional recurrence, or distant metastasis) or death from any cause, whichever occurs first. The 3-year PFS rate is the proportion of participants who remain alive and free from disease progression at 3 years after enrollment.
From enrollment to 3 years post-enrollment (assessed every 3 months for the first 2 years, then every 6 months) or until progression or death

2차 결과 측정

결과 측정
측정값 설명
기간
Objective Response Rate (ORR)
기간: At week 6 (after completion of 2 cycles of neoadjuvant therapy, before surgery)
Proportion of participants achieving complete response (CR) or partial response (PR) after neoadjuvant therapy, assessed by RECIST v1.1 (blinded independent central review).
At week 6 (after completion of 2 cycles of neoadjuvant therapy, before surgery)
R0 Resection Rate
기간: At time of surgery (approximately week 10-12 after enrollment)
Proportion of participants undergoing surgery who achieve microscopically negative margins (no tumor cells at the resection margin on final pathology).
At time of surgery (approximately week 10-12 after enrollment)
Overall Survival
기간: From enrollment up to 5 years (assessed every 3 months for first 2 years, then every 6 months)
Time from enrollment to death from any cause. Participants who are alive at last follow-up will be censored.
From enrollment up to 5 years (assessed every 3 months for first 2 years, then every 6 months)
Local Control Rate
기간: At 1 year, 2 years, and 3 years post-enrollment
Proportion of participants without local recurrence (at primary tumor site) at specified time points.
At 1 year, 2 years, and 3 years post-enrollment
Adverse events
기간: From first dose of study drug until 30 days after last dose or surgery, whichever is later
Incidence, type, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs) assessed by CTCAE version 5.0.
From first dose of study drug until 30 days after last dose or surgery, whichever is later
EORTC QLQ-C30
기간: Baseline, at week 6 (after neoadjuvant therapy), at 6 months, 12 months, 24 months, and 36 months post-enrollment
Change from baseline in EORTC QLQ-C30.
Baseline, at week 6 (after neoadjuvant therapy), at 6 months, 12 months, 24 months, and 36 months post-enrollment
Organ Preservation Rate
기간: At time of surgery (approximately week 10-12 after enrollment)
Proportion of participants who avoid disfiguring surgeries including orbital exenteration, maxillectomy, craniotomy, or skull base resection compared to hypothetical initial surgery without neoadjuvant therapy.
At time of surgery (approximately week 10-12 after enrollment)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Eye & ENT Hospital of Fudan University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2028년 6월 1일

연구 완료 (추정된)

2031년 6월 1일

연구 등록 날짜

최초 제출

2026년 5월 17일

QC 기준을 충족하는 최초 제출

2026년 5월 23일

처음 게시됨 (실제)

2026년 6월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 23일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2026069-1

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

IPD will not be shared due to concerns about participant privacy and limitations of informed consent.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

아데노이드 낭성 암종에 대한 임상 시험

Anlotinib + Epirubicin에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Jamaica

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다