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

2026年8月25日 更新者：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

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

22

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Michigan
      • Detroit、Michigan、アメリカ、48201
        • Karmanos Cancer Institute
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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
薬：Toripalimab
Toripalimab 240mg intravenously every three weeks on weeks 1, 4 and 7 of a 17 week cycle.
他の名前：
  • JS001
  • トゥオイ
  • TAB001
  • ロクトルジ
  • Toripalimab-tpzi
薬：Paclitaxel
Paclitaxel 80mg/m2 intravenously over weekly for 8 weeks on weeks 8-15 of each cycle times 3 cycles

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate (ORR)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival (OS)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Barbara Ann Karmanos Cancer Institute

捜査官

  • 主任研究者：Ammar Sukari, M.D.、Barbara Ann Karmanos Cancer Institute

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月30日

一次修了 (推定)

2028年5月29日

研究の完了 (推定)

2029年5月29日

試験登録日

最初に提出

2026年8月25日

QC基準を満たした最初の提出物

2026年8月25日

最初の投稿 (実際)

2026年8月31日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月31日

QC基準を満たした最後の更新が送信されました

2026年8月25日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 2025-066 (その他の識別子：Turkish Medicines and Medical Devices Agency Clinical Trial Authorization Number)

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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