Solid TumorsPhase 1NIVALISNCT07538479
Controlled Cold Exposure Combined With PD-1/PD-L1 Immunotherapy in Solid Tumors (NIVALIS)
A Phase 1 study testing Investigator-Selected Standard PD-1/PD-L1 Inhibitor-Based Therapy in people with Solid Tumors and Solid Malignancies, run by West China Hospital at 1 site in China.
Trial summary
This is a single-center, prospective, single-arm, open-label phase I exploratory study that plans to enroll 24 participants with solid malignancies. All participants will receive controlled cold exposure in addition to standard PD-1/PD-L1 inhibitor monotherapy or PD-1/PD-L1 inhibitor-based standard combination… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors, Solid Malignancies, Cold Exposure
- What is being tested?
- Investigator-Selected Standard PD-1/PD-L1 Inhibitor-Based Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 30 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age 18-75 years, regardless of sex. 2. Histologically or cytologically confirmed malignant solid tumor. 3. Evaluated by the treating physician or multidisciplinary team (MDT) as currently planned to receive standard PD-1/PD-L1 inhibitor monotherapy or a standard combination regimen containing PD-1/PD-L1 inhibitors.
- 4. Applicable settings include neoadjuvant, perioperative, or conversion therapy, as well as unresectable locally advanced, recurrent, or metastatic disease planned for systemic therapy.
- 5. At least one evaluable lesion; for patients assessed by RECIST 1.1, at least one measurable lesion is required. Patients planned for surgery may also be included if adequate preoperative imaging and postoperative pathological assessment are available, even if RECIST measurability is not fully met.
- 6. ECOG performance status 0-1; selected patients with ECOG 2 may be enrolled at the investigator's discretion if considered able to tolerate the study procedures.
- 7. Expected survival ≥3 months. 8. Adequate major organ function, including hematologic, hepatic, renal, and electrolyte parameters acceptable for clinical study participation.
- 9. Cardiopulmonary function at rest adequate to tolerate the study procedures, without obvious abnormalities indicating intolerance to cold exposure.
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- 10. Toxicities from prior antitumor therapy must have recovered to ≤ Grade 1, except for alopecia or clinically insignificant abnormalities judged by the investigator; for patients previously treated with PD-1/PD-L1 inhibitors, at least 4 weeks must have elapsed before enrollment, and prior related adverse events must have recovered or stabilized sufficiently for re-exposure.
- 11. No clear contraindication to cold exposure, and deemed able to tolerate cold exposure combined with immunotherapy by the investigator.
- 12. Negative pregnancy test for women of childbearing potential; participants of reproductive potential must agree to use effective contraception during the study and for at least 3 months after the last dose.
- 13. Able to understand the study objectives, procedures, and potential risks, and willing to provide written informed consent.
- 14. For participants planned for neoadjuvant, perioperative, or conversion therapy, the investigator must confirm that study procedures will not delay planned surgery or other critical treatments.
Who cannot join
- 1. Participation in another interventional clinical study or receipt of another investigational treatment within 4 weeks before study treatment initiation.
- 2. Uncontrolled active infection, including but not limited to severe bacterial, viral, or fungal infection, or active tuberculosis.
- 3. HIV infection; chronic HBV or HCV infection with uncontrolled viral replication or unacceptable liver function.
- 4. Known severe hypersensitivity to the intended PD-1/PD-L1 inhibitor or its excipients.
- 5. Active autoimmune disease or a requirement for long-term moderate- to high-dose immunosuppressive therapy; physiological replacement-dose steroids may be allowed at the investigator's discretion.
- 6. Prior severe or life-threatening immune-related adverse events during PD-1/PD-L1 inhibitor therapy that have not resolved or are considered high-risk for re-exposure.
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- 7. Significant cardiovascular disease, including but not limited to unstable angina, severe arrhythmia, NYHA class III-IV heart failure, LVEF <50%, or myocardial infarction, stroke, or severe thrombotic events within 6 months.
- 8. Severe chronic respiratory disease, especially conditions likely to worsen under cold stimulation, such as severe COPD or severe asthma.
- 9. Clear contraindications to cold exposure, including prior severe cold-related injury, cold urticaria, cryoglobulinemia, active Raynaud's syndrome, or other diseases judged by the investigator to preclude tolerance to a cold environment.
- 10. Uncontrolled symptomatic central nervous system metastases. 11. Severe psychiatric illness, cognitive impairment, substance abuse, or alcohol dependence that would interfere with compliance.
- 12. Pregnancy or breastfeeding. 13. Uncontrolled diabetes, severe malnutrition, marked frailty, or any other condition judged to make the participant unable to tolerate cold exposure or study procedures.
- 14. Any situation in which study participation may significantly delay standard therapy, planned surgery, or other critical treatment timing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Xuelei Ma, M.D, +86 13408410416, drmaxuelei@gmail.com
About this study
Official title: NIVALIS Trial: A Single-Center, Prospective, Single-Arm, Open-Label Phase I Exploratory Study Evaluating the Safety, Feasibility, and Preliminary Antitumor Activity of Controlled Cold Exposure Combined With PD-1/PD-L1 Immunotherapy in Patients With Solid Tumors
This is a single-center, prospective, single-arm, open-label phase I exploratory study that plans to enroll 24 participants with solid malignancies. All participants will receive controlled cold exposure in addition to standard PD-1/PD-L1 inhibitor monotherapy or PD-1/PD-L1 inhibitor-based standard combination therapy. A 2-day cold acclimation phase will precede formal intervention, consisting of approximately 20°C exposure for 8 hours on Day -2 and approximately 18°C exposure for 10 hours on Day -1. The first combination cycle begins on Day 1 concurrently with PD-1/PD-L1-based treatment, with exposure to an 18°C temperature-controlled hospital room for 12 hours per day for 7 consecutive days. If tolerated, cold exposure may be repeated in subsequent PD-1/PD-L1 treatment cycles. The primary objective is to evaluate safety, tolerability, and feasibility. Secondary objectives are to explore preliminary antitumor activity and the effects on brown adipose tissue activation, peripheral immune profiling, circulating cytokines, metabolomics, gut microbiota, patient-reported outcomes, and tumor immune/metabolic biomarkers when paired tumor tissue is available.
Read the detailed description
This study does not alter the participant's predetermined standard antitumor treatment pathway. It is non-randomized, does not include a parallel thermoneutral control arm, and uses an open-label design. A total of 24 participants are planned to obtain 20 evaluable participants. For early safety protection, staggered enrollment will be used: the first 2 participants will complete the first combination intervention and the dose-limiting toxicity observation window before further enrollment proceeds, provided no predefined unacceptable toxicity is observed. Efficacy and mechanistic endpoints will be explored primarily through longitudinal within-participant comparisons and descriptive analyses.
- Conditions
- Solid Tumors, Solid Malignancies, Cold Exposure, Immunotherapy
- Being tested
- Controlled Cold Exposure, Investigator-Selected Standard PD-1/PD-L1 Inhibitor-Based Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled Cold ExposureOther
Controlled environmental cold exposure in a temperature-controlled hospital room. Cold acclimation includes approximately 20°C for 8 hours on Day -2 and approximately 18°C for 10 hours on Day -1; formal intervention consists of 18°C exposure for 12 hours per day for 7 consecutive days and may be repeated in later cycles if tolerated.
Investigator-Selected Standard PD-1/PD-L1 Inhibitor-Based TherapyDrug
Standard PD-1/PD-L1 inhibitor monotherapy or PD-1/PD-L1 inhibitor-containing standard combination therapy selected according to tumor type, clinical guidelines, and routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Controlled Cold Exposure + Standard PD-1/PD-L1-Based Therapy | Experimental | ll participants will receive standard PD-1/PD-L1 inhibitor monotherapy or PD-1/PD-L1 inhibitor-based standard combination therapy according to tumor type, clinical guidelines, and routine practice, together with controlled cold exposure. A 2-day cold acclimation phase will be performed before formal intervention (approximately 20°C for 8 hours on Day -2 and approximately 18°C for 10 hours on Day -1). The first combination cycle will include exposure to an 18°C temperature-controlled hospital room for 12 hours per day for 7 consecutive days starting on Day 1; if tolerated, the intervention may be repeated in subsequent PD-1/PD-L1 treatment cycles. Receives: Other: Controlled Cold Exposure; Drug: Investigator-Selected Standard PD-1/PD-L1 Inhibitor-Based Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Serious Adverse Events, and Safety-Related Treatment Modifications
The safety of the study treatment will be evaluated by recording adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), immune-related adverse events (irAEs), grade 3-4 TEAEs, and interruptions, delays, or discontinuations of controlled cold exposure or immunotherapy due to adverse events. Results will be reported as the proportion of participants experiencing the corresponding events (%) and the number of events.
Measured: From the start of the first study-related intervention until 30 days after the last protocol-specified treatment or the initiation of a new anticancer therapy, whichever occurs first.
Completion Rate and Adherence to Controlled Cold Exposure
The feasibility of the controlled cold exposure intervention will be evaluated by assessing the completion rate of planned cold exposure, intervention adherence, early withdrawal rate, and interruptions or discontinuations of cold exposure due to intolerance. Results will be reported separately as proportions (%).
Measured: Primarily assessed during the first combined intervention cycle (Day 1 to Day 7), and continuously recorded until completion of the last protocol-specified cold exposure treatment.
Secondary outcomes (16)
Objective Response Rate
Objective response rate is defined as the proportion (%) of participants with evaluable or measurable lesions who achieve a complete response (CR) or partial response (PR) according to RECIST 1.1.
Measured: The first imaging assessment will be performed 6-8 weeks after treatment initiation, and subsequently every 8-12 weeks until disease progression, withdrawal from the study, or study completion, up to 12 months.
Disease Control Rate
Disease control rate is defined as the proportion (%) of participants with evaluable or measurable lesions who achieve complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.
Measured: The first imaging assessment will be performed 6-8 weeks after treatment initiation, and subsequently every 8-12 weeks until disease progression, withdrawal from the study, or study completion, up to 12 months.
Progression-Free Survival
Progression-free survival will be defined as the time from the start of the first study-related intervention to documented disease progression or death from any cause, whichever occurs first.
Measured: From the start of the first study-related intervention until study completion, up to 36 months.
Overall Survival
Overall survival will be defined as the time from the start of the first study-related intervention to death from any cause.
Measured: From the start of the first study-related intervention until study completion, up to 36 months.
Degree of brown adipose tissue activation after the cold exposure cycle
Brown adipose tissue activation after the first cold exposure cycle will be assessed using 18F-FDG PET/CT and reported using prespecified imaging parameters.
Measured: 7 ± 2 days after completion of the first cold exposure cycle.
Change from baseline in the proportion of peripheral blood immune cell subsets
The proportions of peripheral blood immune cell subsets, such as CD8+ T cells, will be measured by flow cytometry and reported as percentages (%), and changes from baseline will be assessed.
Measured: From enrollment to the end of treatment, an average of 3 months.
Change from baseline in plasma metabolomics
Plasma metabolomics will be measured using LC-MS/MS or another prespecified platform, and changes from baseline will be assessed.
Measured: From enrollment to the end of treatment, an average of 3 months.
Change from baseline in the gut microbiota
Changes in the gut microbiota will be assessed using 16S rRNA sequencing or metagenomic sequencing, and changes from baseline will be evaluated.
Measured: From enrollment to the end of treatment, an average of 3 months.
Incidence of cold exposure-related discomfort
The proportion (%) of patients experiencing cold exposure-related adverse symptoms, such as shivering and pain, will be recorded.
Measured: At baseline, daily during the cold adaptation period, and daily during the initial combined intervention phase, until the end of cold exposure. From enrollment to the end of treatment, an average of 3 months.
Changes in Tumor Immune and Metabolic Biomarkers in Paired Tumor Tissue (If Available)
In participants with available paired tumor tissue samples, changes in immune-related and metabolic biomarkers in tumor tissue before and after treatment will be explored.
Measured: At baseline biopsy and at surgical resection, an average of 3 months.
Surgery rate
Among participants who receive neoadjuvant immunotherapy and are scheduled for surgery, the proportion (%) who ultimately undergo surgical treatment will be assessed to reflect surgical feasibility.
Measured: Assessed at the planned time point for surgery, an average of 1 months.
R0 resection rate
Among participants who actually undergo surgery, the proportion (%) achieving R0 resection will be assessed.
Measured: Assessed at the completion of surgery and postoperative pathological evaluation, an average of 1 months.
Pathological response rate
Among participants who actually undergo surgery, pathological response will be assessed according to prespecified pathological response criteria. Results will be reported as the proportion (%) of participants achieving pathological complete response (pCR) and/or major pathological response (MPR), or as pathological response categories.
Measured: Assessed at the completion of surgery and postoperative pathological evaluation, an average of 1 months.
Change from baseline in circulating cytokine concentrations
Circulating cytokine concentrations in serum or plasma, such as IFN-γ, will be measured by ELISA and reported in pg/mL, and changes from baseline will be assessed.
Measured: From enrollment to the end of treatment, an average of 3 months.
Change from baseline in tumor metabolic biomarkers in paired tumor tissue (if available)
In participants with available paired tumor tissue samples, metabolic biomarkers in tumor tissue will be assessed before and after treatment, and changes from baseline will be evaluated.
Measured: From enrollment to the end of treatment, an average of 3 months.
Change from baseline in tumor immune biomarkers in paired tumor tissue (if available)
In participants with available paired tumor tissue samples, tumor immune biomarkers will be assessed in paired tumor tissue before and after treatment, and changes from baseline will be evaluated.
Measured: From enrollment to the end of treatment, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start20 Apr 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuelei Ma MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538479
- Sponsor's protocol ID
- Approval No. 2270 (2025)
- Acronym
- NIVALIS
- Status last verified
- May 2026
- First submitted
- 2 Apr 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share de-identified individual participant data has not yet been finalized. Any future data sharing decision will be made after study completion, in accordance with institutional policies, ethics requirements, participant consent, and applicable regulations.
Publications
Walker ME, Kodani SD, Mena HA, Tseng YH, Cypess AM, Spite M. Brown Adipose Tissue Activation in Humans Increases Plasma Levels of Lipid Mediators. J Clin Endocrinol Metab. 2024 Jun 17;109(7):1837-1849. doi: 10.1210/clinem/dgae016.
PubMed 38198796Lin B, Lin D, Ou X, Wang J, Yu S, Chen G, Wen J. Brown adipose tissue activation and cardiovascular risk following PD-1 antibody therapy in cancer patients: a retrospective cohort study. Eur J Med Res. 2025 Nov 28;30(1):1195. doi: 10.1186/s40001-025-03463-w.
PubMed 41316332Seki T, Yang Y, Sun X, Lim S, Xie S, Guo Z, Xiong W, Kuroda M, Sakaue H, Hosaka K, Jing X, Yoshihara M, Qu L, Li X, Chen Y, Cao Y. Brown-fat-mediated tumour suppression by cold-altered global metabolism. Nature. 2022 Aug;608(7922):421-428. doi: 10.1038/s41586-022-05030-3. Epub 2022 Aug 3.
PubMed 35922508
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIVALIS Trial: A Single-Center, Prospective, Single-Arm, Open-Label Phase I Exploratory Study Evaluating the Safety, Feasibility, and Preliminary Antitumor Activity of Controlled Cold Exposure Combined With PD-1/PD-L1 Immunotherapy in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT07538479
- Acronym / sponsor ID
- NIVALIS / Approval No. 2270 (2025)
- Conditions
- Solid Tumors, Solid Malignancies, Cold Exposure, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, prospective, single-arm, open-label phase I exploratory study that plans to enroll 24 participants with solid malignancies. All participants will receive controlled cold exposure in addition to standard PD-1/PD-L1 inhibitor monotherapy or PD-1/PD-L1 inhibitor-based standard combination therapy. A 2-day cold acclimation phase will precede formal intervention, consisting of approximately 20°C exposure for 8 hours on Day -2 and approximately 18°C exposure for 10 hours on Day -1. The first combination cycle begins on Day 1 concurrently with PD-1/PD-L1-based treatment, with exposure to an 18°C temperature-controlled hospital room for 12 hours per day for 7 consecutive days. If tolerated, cold exposure may be repeated in subsequent PD-1/PD-L1 treatment cycles. The primary objective is to evaluate safety, tolerability, and feasibility. Secondary objectives are to explore preliminary antitumor activity and the effects on brown adipose tissue activation, peripheral immune profiling, circulating cytokines, metabolomics, gut microbiota, patient-reported outcomes, and tumor immune/metabolic biomarkers when paired tumor tissue is available.
Detailed description
This study does not alter the participant's predetermined standard antitumor treatment pathway. It is non-randomized, does not include a parallel thermoneutral control arm, and uses an open-label design. A total of 24 participants are planned to obtain 20 evaluable participants. For early safety protection, staggered enrollment will be used: the first 2 participants will complete the first combination intervention and the dose-limiting toxicity observation window before further enrollment proceeds, provided no predefined unacceptable toxicity is observed. Efficacy and mechanistic endpoints will be explored primarily through longitudinal within-participant comparisons and descriptive analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Controlled Cold Exposure + Standard PD-1/PD-L1-Based Therapy | Experimental | Other: Controlled Cold Exposure, Drug: Investigator-Selected Standard PD-1/PD-L1 Inhibitor-Based Therapyll participants will receive standard PD-1/PD-L1 inhibitor monotherapy or PD-1/PD-L1 inhibitor-based standard combination therapy according to tumor type, clinical guidelines, and routine practice, together with controlled cold exposure. A 2-day cold acclimation phase will be performed before formal intervention (approximately 20°C for 8 hours on Day -2 and approximately 18°C for 10 hours on Day -1). The first combination cycle will include exposure to an 18°C temperature-controlled hospital room for 12 hours per day for 7 consecutive days starting on Day 1; if tolerated, the intervention may be repeated in subsequent PD-1/PD-L1 treatment cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Age 18-75 years, regardless of sex. 2. Histologically or cytologically confirmed malignant solid tumor. 3. Evaluated by the treating physician or multidisciplinary team (MDT) as currently planned to receive standard PD-1/PD-L1 inhibitor monotherapy or a standard combination regimen containing PD-1/PD-L1 inhibitors.
- 4. Applicable settings include neoadjuvant, perioperative, or conversion therapy, as well as unresectable locally advanced, recurrent, or metastatic disease planned for systemic therapy.
- 5. At least one evaluable lesion; for patients assessed by RECIST 1.1, at least one measurable lesion is required. Patients planned for surgery may also be included if adequate preoperative imaging and postoperative pathological assessment are available, even if RECIST measurability is not fully met.
- 6. ECOG performance status 0-1; selected patients with ECOG 2 may be enrolled at the investigator's discretion if considered able to tolerate the study procedures.
- 7. Expected survival ≥3 months. 8. Adequate major organ function, including hematologic, hepatic, renal, and electrolyte parameters acceptable for clinical study participation.
Key exclusion criteria (12 listed)
- 1. Participation in another interventional clinical study or receipt of another investigational treatment within 4 weeks before study treatment initiation.
- 2. Uncontrolled active infection, including but not limited to severe bacterial, viral, or fungal infection, or active tuberculosis.
- 3. HIV infection; chronic HBV or HCV infection with uncontrolled viral replication or unacceptable liver function.
- 4. Known severe hypersensitivity to the intended PD-1/PD-L1 inhibitor or its excipients.
- 5. Active autoimmune disease or a requirement for long-term moderate- to high-dose immunosuppressive therapy; physiological replacement-dose steroids may be allowed at the investigator's discretion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled Cold ExposureControlled environmental cold exposure in a temperature-controlled hospital room. Cold acclimation includes approximately 20°C for 8 hours on Day -2 and approximately 18°C for 10 hours on Day -1; formal intervention consists of 18°C exposure for 12 hours per day for 7 consecutive days and may be repeated in later cycles if tolerated. | Other | Experimental: Controlled Cold Exposure + Standard PD-1/PD-L1-Based Therapy |
| Investigator-Selected Standard PD-1/PD-L1 Inhibitor-Based TherapyStandard PD-1/PD-L1 inhibitor monotherapy or PD-1/PD-L1 inhibitor-containing standard combination therapy selected according to tumor type, clinical guidelines, and routine clinical practice. | Drug | Experimental: Controlled Cold Exposure + Standard PD-1/PD-L1-Based Therapy |
Primary outcome
Incidence of Adverse Events, Serious Adverse Events, and Safety-Related Treatment Modifications
Time frame: From the start of the first study-related intervention until 30 days after the last protocol-specified treatment or the initiation of a new anticancer therapy, whichever occurs first.
The safety of the study treatment will be evaluated by recording adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), immune-related adverse events (irAEs), grade 3-4 TEAEs, and interruptions, delays, or discontinuations of controlled cold exposure or immunotherapy due to adverse events. Results will be reported as the proportion of participants experiencing the corresponding events (%) and the number of events.
Completion Rate and Adherence to Controlled Cold Exposure
Time frame: Primarily assessed during the first combined intervention cycle (Day 1 to Day 7), and continuously recorded until completion of the last protocol-specified cold exposure treatment.
The feasibility of the controlled cold exposure intervention will be evaluated by assessing the completion rate of planned cold exposure, intervention adherence, early withdrawal rate, and interruptions or discontinuations of cold exposure due to intolerance. Results will be reported separately as proportions (%).
16 secondary outcomes
Objective Response Rate
Time frame: The first imaging assessment will be performed 6-8 weeks after treatment initiation, and subsequently every 8-12 weeks until disease progression, withdrawal from the study, or study completion, up to 12 months.
Disease Control Rate
Time frame: The first imaging assessment will be performed 6-8 weeks after treatment initiation, and subsequently every 8-12 weeks until disease progression, withdrawal from the study, or study completion, up to 12 months.
Progression-Free Survival
Time frame: From the start of the first study-related intervention until study completion, up to 36 months.
Overall Survival
Time frame: From the start of the first study-related intervention until study completion, up to 36 months.
Degree of brown adipose tissue activation after the cold exposure cycle
Time frame: 7 ± 2 days after completion of the first cold exposure cycle.
Change from baseline in the proportion of peripheral blood immune cell subsets
Time frame: From enrollment to the end of treatment, an average of 3 months.
Change from baseline in plasma metabolomics
Time frame: From enrollment to the end of treatment, an average of 3 months.
Change from baseline in the gut microbiota
Time frame: From enrollment to the end of treatment, an average of 3 months.
Incidence of cold exposure-related discomfort
Time frame: At baseline, daily during the cold adaptation period, and daily during the initial combined intervention phase, until the end of cold exposure. From enrollment to the end of treatment, an average of 3 months.
Changes in Tumor Immune and Metabolic Biomarkers in Paired Tumor Tissue (If Available)
Time frame: At baseline biopsy and at surgical resection, an average of 3 months.
Surgery rate
Time frame: Assessed at the planned time point for surgery, an average of 1 months.
R0 resection rate
Time frame: Assessed at the completion of surgery and postoperative pathological evaluation, an average of 1 months.
Pathological response rate
Time frame: Assessed at the completion of surgery and postoperative pathological evaluation, an average of 1 months.
Change from baseline in circulating cytokine concentrations
Time frame: From enrollment to the end of treatment, an average of 3 months.
Change from baseline in tumor metabolic biomarkers in paired tumor tissue (if available)
Time frame: From enrollment to the end of treatment, an average of 3 months.
Change from baseline in tumor immune biomarkers in paired tumor tissue (if available)
Time frame: From enrollment to the end of treatment, an average of 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 38198796Walker ME, Kodani SD, Mena HA, Tseng YH, Cypess AM, Spite M. Brown Adipose Tissue Activation in Humans Increases Plasma Levels of Lipid Mediators. J Clin Endocrinol Metab. 2024 Jun 17;109(7):1837-1849. doi: 10.1210/clinem/dgae016.
- Background: PubMed 41316332Lin B, Lin D, Ou X, Wang J, Yu S, Chen G, Wen J. Brown adipose tissue activation and cardiovascular risk following PD-1 antibody therapy in cancer patients: a retrospective cohort study. Eur J Med Res. 2025 Nov 28;30(1):1195. doi: 10.1186/s40001-025-03463-w.
- Background: PubMed 35922508Seki T, Yang Y, Sun X, Lim S, Xie S, Guo Z, Xiong W, Kuroda M, Sakaue H, Hosaka K, Jing X, Yoshihara M, Qu L, Li X, Chen Y, Cao Y. Brown-fat-mediated tumour suppression by cold-altered global metabolism. Nature. 2022 Aug;608(7922):421-428. doi: 10.1038/s41586-022-05030-3. Epub 2022 Aug 3.
- Individual participant dataSharing planned: Undecided. The plan to share de-identified individual participant data has not yet been finalized. Any future data sharing decision will be made after study completion, in accordance with institutional policies, ethics requirements, participant consent, and applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Investigator-Selected Standard PD-1/PD-L1 Inhibitor-Based Therapy in people with Solid Tumors and Solid Malignancies, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuelei Ma, M.D (+86 13408410416, drmaxuelei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Serious Adverse Events, and Safety-Related Treatment Modifications (time frame: From the start of the first study-related intervention until 30 days after the last protocol-specified treatment or the initiation of a new anticancer therapy, whichever occurs first.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07538479, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.