Physician and Patient Preferences for Cell Therapies in Advanced Solid Tumors

NCT07813000 | Recruiting

• 1 other identifier: CellChoice-DCE-V1.0
• Study Type: observational
• Target: 1,020
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumors

Keywords

Discrete choice experiment (DCE); Patient preference; Physician preference; Benefit-risk assessment; Cell therapy; CAR-T cell therapy; Advanced solid tumor

Outcome Measures

Primary Outcomes (1)

• Part-worth utility coefficients (preference weights) for cell therapy benefit-risk attributes

  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

Secondary Outcomes (3)

• Difference in preference weights for cell therapy benefit-risk attributes between patients and physicians

  Day 1

• Maximum acceptable risk (MAR) of treatment-related adverse events in exchange for improved efficacy

  Day 1

• Marginal willingness to pay (mWTP) for improvements in cell therapy attributes

  Day 1

Study Arms (2)

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).

Other: Not applicable- 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).

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

This is an observational study.

Cohort 1: Physicians; Cohort 2: Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Physicians
• Physicians must meet ALL of the following criteria:
• Hold a valid medical practitioner license issued in the People's Republic of China and currently practice at a medical institution in China;
• 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);
• Hold a professional title of attending physician or above;
• 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;
• Have a basic understanding of cell therapies (e.g., CAR-T, TIL, TCR-T, and NK cell therapies) and their therapeutic principles;
• Participate voluntarily and provide electronic informed consent.
• Patients
• Patients must meet ALL of the following criteria:
• Aged 18 years or older;
• 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);
• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with adequate cognitive and physical capacity to complete the questionnaire;
• Able to understand the questionnaire content independently or with assistance from a study coordinator;

You may not qualify if:

• Physicians
• Physicians meeting ANY of the following criteria will be excluded:
• Individuals engaged exclusively in basic research without direct involvement in clinical patient care;
• 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:
• Patients who are unaware of their tumor stage or treatment status;
• Severe cognitive impairment or psychiatric disorders that preclude comprehension of the questionnaire content or independent judgment;
• Estimated life expectancy of less than 3 months as assessed by the treating physician, or insufficient physical capacity to complete the questionnaire;
• Uncontrolled acute illness or other urgent medical conditions that make study participation inadvisable.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Patient Preference

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Weijia Fang, M.D.

CONTACT

86-057187237587; weijiafang@zju.edu.cn

Yang Gao, M.D.

CONTACT

gaoyang954@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: September 10, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)