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Sequential Toripalimab and Paclitaxel in Patients With Head and Neck Squamous Cell Cancer (HNSCC) and Poor Performance Status (HNSCC)

2026년 8월 25일 업데이트: Ammar Sukari, Barbara Ann Karmanos Cancer Institute

A Phase 2 Pilot Study of the Role of Sequential Immune Checkpoint Inhibitor Toripalimab and Chemotherapy Paclitaxel in Patients With HNSCC and ECOG Performance Score of 2

The goal of this clinical trial is to learn if the drug Toripalimab can prime the tumor to optimize response to Paclitaxel in HNSCC patients with a decrease performance status in a way that make both drugs well tolerated and improve partial or complete response rate over each treatment. The main questions it aims to answer are:

  • What is the response rate of the cancer to paclitaxel after priming with toripalimab
  • What is the time to progression if we continue to cycle between toripalimab and paclitaxel
  • What is the impact on the patient's quality of life and overall survival

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

Toripalimab treatment will be administered on an outpatient basis. Toripalimab will be given in the clinic on Day 1. Intravenous (IV) infusions will be given every three weeks thereafter for the first seven weeks of the study. Administration follows standard of care.

Paclitaxel treatment will be administered on an outpatient basis as per standard of care once weekly for a total of eight weeks during Weeks 8-15 of each cycle. Premedication and administration follow standard of care. After eight weeks of chemotherapy, the participant finishes the cycle with two weeks of rest (no treatment).

This will be repeated for a total of 51 weeks total of 3 cycles (each cycle is 17 weeks) We will study sequential ICI and CT on HNSCC, and the impact on quality of life in addition to studying the tumor microenvironment. Participants undergo an optional biopsy before and after eight weeks of weekly paclitaxel. To explore the cytotoxic signature, we will calculate the enrichment scores for canonical cytotoxic markers (GZMA, GZMB, GZMK, GNLY, IFNG, PRF1 and NKG7). To estimate the signature of collagen formation, we will calculate enrichment scores using the gene lists from the REACTOME_COLLAGEN_FORMATION pathway (msigdb.v7.5.1.symbols.gmt; https://www.gsea-msigdb.org/gsea/index.jsp). To explore the cell type contexts, we will perform principal component analysis (PCA) and then uniform manifold approximation and projection (UMAP) using the RunPCA and RunUMAP functions based on the cell type proportion inferred by spatial transcriptomics deconvolution (STRIDE). Results will be summarized using descriptive statistics, including mean, median, standard deviation, range, count, and percentage, as appropriate.

연구 유형

중재적

등록 (추정된)

22

단계

  • 2 단계

연락처 및 위치

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

연구 연락처

연구 장소

  • 미국
    • Michigan
      • Detroit, Michigan, 미국, 48201
        • Karmanos Cancer Institute
        • 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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Participants must have histologically confirmed HNSCC deemed to be metastatic or incurable by the treating physician. Participants can have incurable disease at presentation or have been treated with definitive curable surgical resection, chemoradiotherapy (CRT), or both, then relapsed with non-curable disease. Participants diagnosed with HNSCC stage IV-C or metastatic/non-resectable, relapsed disease are eligible for this study
  • Participant must have measurable disease, defined by RECIST v1.1.
  • Participant must be able to understand a written informed consent document and be willing to sign it.
  • Participants must be 18 years of age or older.
  • Participant must have a life expectancy of at least six months.
  • Participant must have an ECOG performance score of 2.

  • Participant must have:

    1. Total bilirubin ≤ 3 times upper limit of normal (ULN)
    2. Hemoglobin > 8 g/dL. Transfusion is permitted
    3. Absolute neutrophil count (ANC) > 1.0 K/mm3. Granulocyte colony-stimulating factor (G-CSF) is NOT permitted
  • Paclitaxel has known embryo- and fetotoxic effects. Therefore, women of childbearing potential must agree to avoid becoming pregnant and male participants should avoid impregnating a female partner and donating sperm starting at initiation of treatment up until at least 30 days after last dose of toripalimab or paclitaxel.

Exclusion Criteria:

  • Participants with known untreated brain metastases will be excluded from this clinical trial. Stable brain metastases will be allowed, and it will be confirmed by stable brain MRI with and without contrast within 8 weeks of signing consent.
  • Participants with uncontrolled chronic obstructive pulmonary disease (COPD), heart disease, or autoimmune disease, in the opinion of the treating physician.
  • Participants who are taking any other investigational drugs.

  • Participants who are taking prednisone or equivalent steroid >10 mg per day prior to the start of treatment.

    • The washout period is at the treating physician's discretion.
    • Once participants are on study, they may be treated with steroids and other immunosuppressants per standard of care.
  • Participants with a history of allergic reactions attributed to toripalimab, paclitaxel, or medicines containing Kolliphor ELP (Polyoxyl 35 Castor Oil, NF).
  • Participants who are pregnant or breastfeeding. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued.
  • Participants who have end-stage renal failure are eligible for this study unless they have had a kidney transplant.
  • Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to follow the treatment plan.

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: Toripalimab plus Paclitaxel
Toripalimab 240mg on weeks 1, 4 and 7 in combination with Paclitaxel 80mg/m2 weeks 8-15 with a rest on Weeks 16-17 for 3 cycles. One cycle equals 17 weeks
의약품: Toripalimab
Toripalimab 240mg intravenously every three weeks on weeks 1, 4 and 7 of a 17 week cycle.
다른 이름들:
  • JS001
  • 뚜이
  • 탭001
  • 록토르지
  • Toripalimab-TPZI
의약품: Paclitaxel
Paclitaxel 80mg/m2 intravenously over weekly for 8 weeks on weeks 8-15 of each cycle times 3 cycles

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Objective Response Rate (ORR)
기간: Up to 1 year after treatment initiation
The ORR is calculated as the proportion of participants with complete response (CR) or partial response (PR) per RECIST v1.1 among all treated participants. CR is the disappearance of all lesions; PR is at least a 30% decrease in the sum of diameters of target lesions. The two-sided 95% confidence interval (CI) for ORR will be estimated using Clopper-Pearson's method.
Up to 1 year after treatment initiation

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival (OS)
기간: Up to 2 years after treatment initiation
The OS is the length of time from the start of treatment that participants are still alive. The distribution of OS will be graphically summarized using a Kaplan-Meier (KM) curve with corresponding median and two-sided 95% CIs computed using KM estimates.
Up to 2 years after treatment initiation
Progression Free Survival (PFS)
기간: Up to 1 year after treatment initiation
PFS is defined as the time duration from treatment start to progression or death from any cause, whichever occurs first. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions. The distribution of PFS will be graphically summarized using a KM curve with corresponding median and two-sided 95% CIs computed using KM estimates.
Up to 1 year after treatment initiation
Duration of Response (DOR)
기간: Up to 2 years after treatment initiation
DOR is the length of time that a tumor continues to respond to treatment without the cancer growing or spreading. The distribution of DOR will be graphically summarized using a KM curve with corresponding median and two-sided 95% CIs computed using KM estimates.
Up to 2 years after treatment initiation
Impact on Quality of Life (QOL)
기간: Up to 1 year after treatment initiation
QOL will be measured using the Functional Assessment of Cancer Therapy for Head & Neck cancer (FACT-H&N). The distribution of QOL will be assessed, and if necessary, a data transformation will be applied to meet normality assumptions. Longitudinal QOL will be summarized using the mean, median, standard deviation (SD), range, and 95% CI across all time points. Minimally important differences (MID) in FACT scores will be determined; for FACT-General the MID is 3 to 7 and for all the subscales the MID is 2 to 3.
Up to 1 year after treatment initiation

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Barbara Ann Karmanos Cancer Institute

수사관

  • 수석 연구원: Ammar Sukari, M.D., Barbara Ann Karmanos Cancer Institute

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 9월 30일

기본 완료 (추정된)

2028년 5월 29일

연구 완료 (추정된)

2029년 5월 29일

연구 등록 날짜

최초 제출

2026년 8월 25일

QC 기준을 충족하는 최초 제출

2026년 8월 25일

처음 게시됨 (실제)

2026년 8월 31일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 31일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 25일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2025-066 (기타 식별자: Turkish Medicines and Medical Devices Agency Clinical Trial Authorization Number)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

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. .

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