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Physician and Patient Preferences for Cell Therapies in Advanced Solid Tumors

2026년 9월 4일 업데이트: Weijia Fang, MD, Zhejiang University

Physician and Patient Preferences for Cell Therapies in Advanced Solid Tumors: A Discrete Choice Experiment

Cell therapies - including chimeric antigen receptor T-cell (CAR-T) therapy, tumor-infiltrating lymphocyte (TIL) therapy, T-cell receptor-engineered T-cell (TCR-T) therapy, and natural killer (NK) cell therapy - are emerging treatments for advanced solid tumors. However, their benefit-risk profiles remain uncertain: objective response rates in solid tumors are generally low, treatment-related toxicities such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) can be severe, and the manufacturing process is lengthy and costly. Little is known about how physicians and patients weigh these benefits, risks, and burdens when considering cell therapy for advanced solid tumors.

This cross-sectional, survey-based observational study will use a discrete choice experiment (DCE) to quantify and compare treatment preferences among approximately 420 oncology physicians and 600 patients with advanced solid tumors in China. Each participant will complete a one-time online questionnaire containing a series of hypothetical treatment choices. The study will estimate the relative importance of key treatment attributes (efficacy, safety, treatment burden, and cost), the maximum acceptable risk that participants are willing to tolerate in exchange for improved efficacy, and differences in preferences between physicians and patients. The findings will inform shared decision-making, cell therapy development, regulatory benefit-risk assessment, and health policy.

연구 개요

상세 설명

This is a cross-sectional, questionnaire-based observational study using a discrete choice experiment (DCE) to elicit treatment preferences from oncology physicians and patients with advanced solid tumors. The study is designed and will be reported in accordance with the ISPOR good research practice guidelines for conjoint analysis. DCE attributes and levels will be developed through a structured process combining a literature review, expert consultation, and cognitive pretesting, and will span the efficacy, safety, treatment burden, and cost domains. A D-optimal fractional factorial design will be used to generate the choice tasks; each participant will be randomly assigned to a block of choice tasks, each presenting pairs of unlabeled hypothetical cell therapy profiles. Preference weights (part-worth utilities) will be estimated using random-parameters logit (mixed logit) models. Secondary analyses will examine the relative importance of attributes, maximum acceptable risk (MAR), marginal willingness to pay (mWTP) where applicable, differences in preferences between physicians and patients, and preference heterogeneity using latent class analysis and interaction-term models. Prespecified sensitivity analyses will be conducted to assess the robustness of the findings.

연구 유형

관찰

등록 (추정된)

1020

연락처 및 위치

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

연구 연락처

연구 연락처 백업

연구 장소

    • Zhejiang
      • Hangzhou, Zhejiang, 중국, 310000
        • 모병
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • 연락하다:
        • 수석 연구원:
          • Weijia Fang, M.D.

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

샘플링 방법

비확률 샘플

연구 인구

Approximately 420 licensed oncology physicians and 600 adult patients with advanced solid tumors will be enrolled in China.

설명

Inclusion Criteria:

  • Physicians

Physicians must meet ALL of the following criteria:

  1. Hold a valid medical practitioner license issued in the People's Republic of China and currently practice at a medical institution in China;
  2. Specialize in medical oncology or another specialty directly involved in the diagnosis and treatment of solid tumors (e.g., thoracic oncology, gastrointestinal oncology, genitourinary oncology, or gynecologic oncology; surgical oncologists or radiation oncologists with prescribing authority for systemic anticancer therapy are also eligible);
  3. Hold a professional title of attending physician or above;
  4. Have directly participated in systemic treatment decision-making for patients with advanced (unresectable stage III or stage IV) solid tumors within the past 12 months;
  5. Have a basic understanding of cell therapies (e.g., CAR-T, TIL, TCR-T, and NK cell therapies) and their therapeutic principles;
  6. Participate voluntarily and provide electronic informed consent.

    • Patients

Patients must meet ALL of the following criteria:

  1. Aged 18 years or older;
  2. Histologically or cytologically confirmed advanced solid tumor (unresectable stage III or stage IV; e.g., non-small cell lung cancer, hepatocellular carcinoma, colorectal cancer, gastric cancer, melanoma, or ovarian cancer);
  3. Received at least one prior line of systemic anticancer therapy (chemotherapy, targeted therapy, immune checkpoint inhibitors, or other cellular immunotherapy) in the advanced or metastatic setting;
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with adequate cognitive and physical capacity to complete the questionnaire;
  5. Able to understand the questionnaire content independently or with assistance from a study coordinator;
  6. Participate voluntarily and provide electronic informed consent.

Exclusion Criteria:

  • Physicians

Physicians meeting ANY of the following criteria will be excluded:

  1. Individuals engaged exclusively in basic research without direct involvement in clinical patient care;
  2. Individuals unable, for any reason, to understand the questionnaire content or make independent judgments.

    • Patients

Patients meeting ANY of the following criteria will be excluded:

  1. Patients who are unaware of their tumor stage or treatment status;
  2. Severe cognitive impairment or psychiatric disorders that preclude comprehension of the questionnaire content or independent judgment;
  3. Estimated life expectancy of less than 3 months as assessed by the treating physician, or insufficient physical capacity to complete the questionnaire;
  4. Uncontrolled acute illness or other urgent medical conditions that make study participation inadvisable.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Cohort 1: Physicians
Licensed oncology physicians who have participated in systemic treatment decision-making for patients with advanced solid tumors within the past 12 months (approximately 420 participants).
This is an observational study.
Cohort 2: Patients
Adults with histologically or cytologically confirmed advanced solid tumors (unresectable stage III or stage IV) who have received at least one prior line of systemic anticancer therapy (approximately 600 participants).
This is an observational study.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Part-worth utility coefficients (preference weights) for cell therapy benefit-risk attributes
기간: Day 1
Preference weights (part-worth utility coefficients) for all attribute levels will be estimated using a random-parameters logit (mixed logit) model, fitted separately in the physician and patient cohorts. Each coefficient represents the marginal change in utility associated with moving from the reference level to a given attribute level. The unit of measure is the preference weight, reported with 95% confidence intervals; within an attribute, a higher weight indicates a more preferred level.
Day 1

2차 결과 측정

결과 측정
측정값 설명
기간
Difference in preference weights for cell therapy benefit-risk attributes between patients and physicians
기간: Day 1
Between-group differences in preference weights will be evaluated using the Swait-Louviere scale parameter test, a chi-square test of whether the two groups' choice data can be pooled into a single model, accounting for differences in scale (error variance) between groups. The unit of measure is the chi-square test statistic.
Day 1
Maximum acceptable risk (MAR) of treatment-related adverse events in exchange for improved efficacy
기간: Day 1
Maximum acceptable risk (MAR) is the maximum acceptable percentage-point increase in a treatment-related risk that participants are willing to tolerate in exchange for a defined improvement in efficacy. MAR will be calculated from the estimated preference weights as the negative of the ratio between the marginal utility of the efficacy improvement and the marginal disutility of the risk increase from the lowest level of that risk included in the DCE. The unit of measure is percentage points of treatment-related risk.
Day 1
Marginal willingness to pay (mWTP) for improvements in cell therapy attributes
기간: Day 1
Marginal willingness to pay (mWTP) will be calculated as the negative ratio of the preference weight of a non-cost attribute level to the coefficient of the cost attribute. The unit of measure is Chinese yuan (CNY), representing the additional out-of-pocket expense participants are willing to pay for a given attribute level relative to its reference level.
Day 1

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

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 1일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2027년 12월 31일

연구 등록 날짜

최초 제출

2026년 8월 19일

QC 기준을 충족하는 최초 제출

2026년 9월 4일

처음 게시됨 (실제)

2026년 9월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 4일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

All results will be reported in aggregate form (e.g., means with 95% confidence intervals); no individual-level physician or patient data will be disclosed.

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. .

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