OncoMatch/Clinical Trials/NCT07847359
Cryoablation Combined With Hepatic Arterial Infusion of Iparomlimab and Tuvonralimab (QL1706), Intravenous Dacarbazine, and Oral Lenvatinib in Patients With Liver Metastases From Malignant Melanoma: a Single-arm, Phase II, Prospective Trial
Official title: The Efficacy and Safety of Cryoablation Combined With Hepatic Arterial Infusion of Iparomlimab and Tuvonralimab (QL1706), Intravenous Dacarbazine, and Oral Lenvatinib in Patients With Liver Metastases From Malignant Melanoma: a Single-arm, Phase II, Prospective Trial (Cryo-IA-Check-002)
Is NCT07847359 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Iparomlimab and Tuvonralimab and Dacarbazine for melanoma (skin) stage iv.
Treatment: Iparomlimab and Tuvonralimab · Dacarbazine · Lenvatinib — To explore the efficacy and safety of cryoablation combined with hepatic arterial infusion of iparomlimab and tuvonralimab, intravenous dacarbazine, and oral lenvatinib in patients with liver metastases from malignant melanoma.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Melanoma
Disease stage
Required: Stage IV
Metastatic disease required
Presence of liver metastases, with at least one lesion assessed as suitable for cryoablation; At least one target lesion suitable for efficacy assessment according to RECIST 1.1
Performance status
ECOG 0–0(Fully active)
Demographics
Prior therapy
Must have received: standard treatment for malignant melanoma
Patients with pathologically confirmed metastatic malignant melanoma after failure of standard treatment
Cannot have received: radiotherapy to liver metastases
Liver metastases previously treated with radiotherapy
Cannot have received: microwave ablation to liver metastases
Liver metastases previously treated with microwave ablation
Cannot have received: radiofrequency ablation to liver metastases
Liver metastases previously treated with radiofrequency ablation
Cannot have received: irreversible electroporation to liver metastases
Liver metastases previously treated with irreversible electroporation
Cannot have received: immune checkpoint inhibitor
Exception: complicated by grade 3 or higher immune-related adverse events
Previous treatment with immune checkpoint inhibitors complicated by grade 3 or higher immune-related adverse events
Cannot have received: lenvatinib or other multi-target tyrosine kinase inhibitors (lenvatinib)
Previous treatment with lenvatinib or other multi-target tyrosine kinase inhibitors
Cannot have received: systemic chemotherapy containing dacarbazine or temozolomide (dacarbazine, temozolomide)
Exception: complicated by grade 3 or higher myelosuppression or hepatotoxicity during treatment
Previous systemic chemotherapy containing dacarbazine or temozolomide complicated by grade 3 or higher myelosuppression or hepatotoxicity during treatment
Lab requirements
Blood counts
Neutrophil count ≥ 1.8 × 10⁹/L; WBC ≥ 3.0 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; INR < 1.3 or PT < ULN + 2s
Kidney function
Serum creatinine ≤ 1.5 × ULN
Liver function
Serum ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 1.0 × ULN; Albumin ≥ 35 g/L; Child-Pugh score < 7; no decompensated liver function (massive ascites, GI bleeding, hepatic encephalopathy, bilirubin encephalopathy)
Cardiac function
No myocardial infarction, severe/unstable angina, CHF, cerebrovascular accident, or pulmonary embolism within 12 months; no NYHA class II or higher CHF; no severe arrhythmia not controlled by medication; no significant ECG abnormalities on 3 consecutive recordings at least 5 min apart
Laboratory test results meeting the following criteria: ... (see full list in inclusion criteria); Child-Pugh score ≥ 7; decompensated liver function ... [excluded]; ... myocardial infarction, severe or unstable angina, congestive heart failure, cerebrovascular accident, or pulmonary embolism within 12 months [excluded]; ... NYHA class II or higher congestive heart failure, severe arrhythmia not controlled by medication, clinically significant electrocardiographic abnormalities on three consecutive recordings obtained at least 5 minutes apart [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07847359 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiotherapy to liver metastases, microwave ablation to liver metastases, radiofrequency ablation to liver metastases disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages