Controlled Cold Exposure Combined With PD-1/PD-L1 Immunotherapy in Solid Tumors (NIVALIS)
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.
| Condition(s) | Solid Tumors, Solid Malignancies, Cold Exposure, Immunotherapy |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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 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 primar |
| Who can participate | Inclusion Criteria: * 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 RECIS |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | West China Hospital |
| Locations | Chengdu, Sichuan, China |
| Start date | 2026-04-20 |
| NCT ID | NCT07538479 |
| Official listing | https://clinicaltrials.gov/study/NCT07538479 |