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Albumin-bound Paclitaxel Combined With Cisplatin Versus Docetaxel Combined With Cisplatin Induced Chemotherapy in Advanced Head and Neck Squamous Tummor

A Prospective Randomized Controlled Clinical Study of Albumin-bound Paclitaxel Combined With Cisplatin (AP Regimen) Versus Docetaxel Combined With Cisplatin (TP Regimen) Induced Chemotherapy in Advanced Head and Neck Squamous Tummor

Research Topic:

A prospective randomized controlled clinical study of albumin-bound paclitaxel combined with cisplatin (AP regimen) versus docetaxel combined with cisplatin (TP regimen) induced chemotherapy in advanced head and neck squamous cell carcinoma

Expected study duration:

Each subject received a 3-week regimen of AP or TP over 2 cycles.

Research objectives:

To evaluate the efficacy and safety of induction chemotherapy with albumin-bound paclitaxel in patients with advanced head and neck squamous cell carcinoma (HSCC), two induction chemotherapy regimens, AP regimen and TP regimen, were compared.

Trial Design. Single center, open label, controlled clinical study Number of cases: 116 Objective response rate (ORR=CR+PR) was used as the main evaluation index in this study.

연구 개요

상태

알려지지 않은

상세 설명

Research purposes:Research the effectiveness and safety of albumin-bound paclitaxel for induction chemotherapy in patients with advanced head and neck squamous cell carcinoma were evaluated,by comparing the AP regimen and the TP regimen .

Research content:To evaluate the effectiveness and safety of albumin-bound paclitaxel for induction chemotherapy in patients with advanced head and neck squamous cell carcinoma.

Study endpoint Primary endpoint: Objective response rate (ORR=CR+PR) (Assessed according to RECIST standards, see Annex 1) Secondary study endpoint: Surgical resection rate,Pathological remission rate,Progression-free survival (PFS), Overall survival (OS) Main safety indicators: Observe any adverse events that occurred in all subjects during the clinical study and within 1 month after stopping the drug, including clinical symptoms, abnormal vital signs, and abnormalities in laboratory examinations, and record their clinical features, Severity, time of occurrence, duration, treatment method and prognosis outcome, and determine its correlation with the study drug. The safety of the drug was evaluated according to the NCI-CTC AE 4.0 standard.

Study design:This is a single-center, open-label, controlled clinical study.The aime is observing and evaluating the effectiveness and safety of albumin-bound paclitaxel for induction chemotherapy in patients with advanced head and neck squamous cell carcinoma.

This study is planned to be carried out in Tianjin Cancer Hospital. According to the research principles of GCP.

The study plans to recruit 116 qualified subjects. This study used objective response rate (ORR=CR+PR) as the main evaluation index. According to previous reports, the ORR of the TP group was 50%, and the ORR of the AP group was estimated to be 75%. The test level is set to 0.05 on one side, the test power is set to 0.8, and the estimated dropout rate is 20%. Using the Logrank-Lakatos algorithm, the total sample size is calculated to be 116 cases.

연구 유형

중재적

등록 (예상)

116

단계

  • 4단계

연락처 및 위치

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연구 장소

    • Tianjin
      • Tianjin, Tianjin, 중국, 300000
        • 모병
        • Tianjin Medical University Cancer Institute and Hospital

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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Inclusion criteria:

    1. Age ≥18 years old, male or female;
    2. Subjects had squamous cell carcinoma of the head and neck confirmed by histrohistology or cytology;
    3. CLINICAL STAGE III OR IV WITHOUT DISTANT METASTASES (AJCC 8th)
    4. Patients who have not previously received initial treatment with chemotherapy or radiation;
    5. KPS acuity 70;
    6. Normal bone marrow reserve function and normal liver and kidney function;
    7. Expected survival time ≥3 months;
    8. Subjects of child-bearing age must agree to use effective contraceptive measures during the study period; The serum or urine pregnancy test must be negative for women of childbearing age 72 hours before the start of chemotherapy;
    9. Subjects have good compliance, can carry out treatment and follow-up, and voluntarily abide by the regulations of this study;
    10. Subjects voluntarily sign the informed consent.

Exclusion Criteria:

  • Exclusion criteria:

    1. Patients with distant metastasis;
    2. The presence of uncontrolled serious medical diseases, such as combined with serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
    3. The presence of dementia, altered mental status or any mental illness that would prevent understanding or giving informed consent or filling out questionnaires;
    4. Subjects with grade ≥2 peripheral neuropathy according to CTCAE V5.0;
    5. A history of allergy or hypersensitivity to any therapeutic ingredient;
    6. Suffered from malignant tumors other than squamous cell carcinoma of the head and neck in the past 5 years, except adequately treated basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;
    7. Abnormal results of physical and laboratory tests:

      A) Hematologic abnormalities are defined as:

      I) Absolute count of neutrophils (ANC) : < 1.5×109 / L; Ii) Platelet (PLT) count: < 100×109/L; Iii) Hemoglobin (Hb) level < 90g/L;

      B) Abnormal liver function is defined as:

      I) Total bilirubin (TBIL) level: 1.5 times of the upper limit of normal value of > (ULN); Ii) AST and ALT levels of >ULN were 2.5 times, and BBB>N was 5 times if liver metastasis was present;

      C) Definition of abnormal renal function:

      1.5 times of serum creatinine > ULN, or the calculated creatinine clearance rate < 50ml/min;

    8. Patients who need to be treated with other anti-tumor drugs;
    9. Has received any other investigational drug therapy or participated in another interventional clinical trial within 30 days prior to screening;
    10. The researcher considers it unsuitable for inclusion;
    11. Pregnant or lactating women.

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: albumin-bound paclitaxel combined with cisplatin (AP regimen)
Paclitaxel (albumin combined type) 260 mg/m2, intravenous drip, d1, every three weeks for a cycle, a total of dosing 2 cycles; Cisplatin: 75 mg/m2, intravenous drip, d1, every three weeks for a cycle, a total of dosing 2 cycles;
Paclitaxel for injection (albumin-bound) uses human serum albumin as the carrier to avoid the use of organic solvents for intravenous injection of paclitaxel, reducing the incidence of allergic reactions, and reducing the toxicity of the drug.
다른 이름들:
  • 도세탁셀
활성 비교기: docetaxel combined with cisplatin (TP regimen)
docetaxel: 75 mg/m2, intravenous drip, d1, every three weeks for a cycle, a total of dosing 2 cycles; cisplatin: 75 mg/m2, d1 every three weeks for a cycle, a total of dosing 2 cycles;
Paclitaxel for injection (albumin-bound) uses human serum albumin as the carrier to avoid the use of organic solvents for intravenous injection of paclitaxel, reducing the incidence of allergic reactions, and reducing the toxicity of the drug.
다른 이름들:
  • 도세탁셀

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Objective response rate
기간: 21 days
ORR=CR+PR
21 days

2차 결과 측정

결과 측정
측정값 설명
기간
운영체제
기간: 5년
전반적인 생존
5년
Surgical resection rate
기간: 1 month
the rate of Surgical resection in all samples
1 month
pathological response rate
기간: 1 month
the rate of pathological response in all samples
1 month
PFS
기간: 5 year
progression-free survival
5 year

기타 결과 측정

결과 측정
측정값 설명
기간
부작용 발생률
기간: 90일
부작용 발생률
90일

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Xudong Wang, MD, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center of Cancer

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)

2020년 12월 12일

기본 완료 (예상)

2021년 11월 1일

연구 완료 (예상)

2021년 12월 1일

연구 등록 날짜

최초 제출

2021년 1월 29일

QC 기준을 충족하는 최초 제출

2021년 2월 19일

처음 게시됨 (실제)

2021년 2월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 2월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 2월 19일

마지막으로 확인됨

2020년 11월 1일

추가 정보

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아니

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albumin-bound paclitaxel에 대한 임상 시험

구독하다