A Phase 2 interventional study of Cryoablation and Iparomlimab and Tuvonralimab in Melanoma (Skin) Stage IV, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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Among 203 studies in Melanoma with a site in China — 83 open to participants now, 96 under way, 5 of them phase 3. Melanoma · China.
Among the 203 studies in Melanoma with a site in China, this one is the 150th largest by planned enrollment of the 189 interventional ones that give a count, is one of 20 that started in 2026, is one of 75 in phase 2, reaches primary completion later than 81 of the 95 other live ones, and was the 202nd registered.
3,372 studies on the registry are indexed under Melanoma; 580 are open to participants now.
Browse Melanoma studies →83 of the 203 studies in Melanoma with a site in China are open now. Recruiting first, the newest first:
Sichuan Baili Pharmaceutical Co., Ltd. · Sites in China
Ages 18–75
Sun Yat-sen University · Sites in China
Ages 18+
Peking University Third Hospital · Sites in China
Ages 18+
Bristol-Myers Squibb · Sites in China, United States, Belgium and 10 more countries
Ages 18+
Shanghai Henlius Biotech · Sites in China
Ages 18–70
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 468 Melanoma studies recruiting now, 381 (81%) set no upper age limit and 49 (10%) stop at 75 or younger; 47 take children under 18; 29 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
203 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 91 · Phase 2 110 · Phase 3 13 · Phase 4 2
First in 2008; this study’s year is marked. 20 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 28 is below the median of 40 across 2,650 interventional studies indexed under Melanoma.
Median enrollment 50 across the 189 interventional studies, 75 across the 14 observational. Of the 43 that completed or were terminated, 12 (28%) have results posted.
This tab as a report to print or save as PDF → With an account.
100 of 203 have an industry lead sponsor. The 10 most frequent:
Sun Yat-sen University is the lead sponsor of 1,691 studies on the registry; 619 are open to participants now.
Sun Yat-sen University has 7 studies filed under Melanoma — fewer than ten, so there is no comparison to draw.
24 of the studies in Melanoma with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06008106Phase 3Shanghai Kechow Pharma, Inc.Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma | 2027-09-22 |
| NCT07280832Shanghai JMT-Bio Inc.Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma and Urinary Tract Tumors | 2026-11-30 |
| NCT06359860Beijing Scitech-Mq Pharmaceuticals LimitedA Study of ST-1898 for Unresectable or Metastatic Melanoma | 2026-12 |
| NCT07586891Xijing HospitalExploratory Study With Parallel Controls on the Safety and Efficacy of Neoadjuvant Low Branched-Chain Amino Acid Diet in Combination With Anti-PD-1 Monoclonal Antibody for Stage III Melanoma | 2026-12 |
| NCT07586904Xijing HospitalEfficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III/IV Melanoma. | 2026-12 |
Add all 24 to your calendar (.ics) → With an account.
Among the 203 studies in Melanoma with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Cryoablation combined with PD-1 blockade has shown encouraging efficacy in melanoma patients with liver metastases, but the response rate remains unsatisfactory and the prognosis is still poor. Our previous CryoCheck-001 study of cryoablation plus sintilimab yielded a response rate of less than 30%. Iparomlimab and tuvonralimab (QL1706) is a novel dual PD-1/CTLA-4 combination antibody with a favorable safety profile, and hepatic arterial infusion of immune checkpoint inhibitors has been confirmed to be effective and safe in melanoma liver metastases. Moreover, adding dacarbazine and lenvatinib may further enhance the efficacy of cryoablation combined with immunotherapy. Herein, we aimed to evaluate the efficacy and safety of cryoablation combined with hepatic arterial infusion of QL1706, intravenous dacarbazine, and oral lenvatinib in patients with liver metastases from malignant melanoma. This is a single-arm, phase II, prospective trial using a Simon two-stage design. Patients receive 1-4 cycles of quadruple therapy (cryoablation plus hepatic arterial infusion of QL1706, intravenous dacarbazine, and oral lenvatinib), followed by maintenance with intravenous QL1706, dacarbazine, and oral lenvatinib until disease progression or intolerable toxicity. The primary endpoint is ORR; secondary endpoints include PFS, OS, and treatment-related adverse events.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Laboratory test results meeting the following criteria:
Exclusion Criteria:
Clinical stability requires all of the following:
no new neurological symptoms, and previous neurological symptoms have returned to normal.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single-arm, open-label, phase II trial. Patients receive quadruple therapy for 1-4 cycles (3-4 weeks per cycle): (1) cryoablation of intrahepatic lesions; (2) hepatic arterial infusion of iparomlimab and tuvonralimab (QL1706) 7.5 mg/kg over 2 hours, 7-14 days after ablation; (3) intravenous dacarbazine 850-1000 mg/m² divided over 2 days; (4) oral lenvatinib 8 mg once daily. After completing the combination phase, patients enter maintenance with intravenous QL1706, dacarbazine, and oral lenvatinib until disease progression or intolerable toxicity. If oligoprogression occurs in the liver, radical radiotherapy to progressing intrahepatic lesions is permitted while maintenance continues.
Procedure: Cryoablation · Drug: Iparomlimab and Tuvonralimab · Drug: Dacarbazine · Drug: Lenvatinib
Cryoablation is performed using the Hygea Co-ablation System (Hygea Medical Technology Co. Ltd, Beijing, China), a combined cryoablation and hyperthermic ablation device. Under CT guidance and local anesthesia with 2% lidocaine, one to five intrahepatic lesions with a maximum diameter \<5 cm are ablated per session. Each ablation consists of two 10-minute freeze cycles, with a passive thaw between cycles. Technical success is defined as ice-ball extension of at least 0.5 cm beyond the tumor margin. Cryoablation is mandatory in the first cycle and may be repeated in subsequent cycles at the discretion of the investigator, for a maximum of four sessions within 3 months.
Drug pages: Iparomlimab · Tuvonralimab
Iparomlimab and tuvonralimab (QL1706; Qilu Pharmaceutical Co., Ltd., Jinan, China) is a dual PD-1/CTLA-4 combination antibody. During the combination phase, QL1706 is administered by hepatic arterial infusion. The catheter tip is positioned in the tumor-feeding artery, proper hepatic artery, or left/right hepatic artery based on intra-hepatic tumor location, and correct positioning is confirmed by repeat angiography. QL1706 7.5 mg/kg diluted in 100 mL of 0.9% normal saline is then infused at a constant rate over 2 hours. Hepatic arterial infusion is given every 3 weeks for a maximum of 4 cycles within 3 months, and if combined with cryoablation, it is administered 7-14 days after ablation. During the maintenance phase, QL1706 is administered intravenously at the same dose every 3 weeks until disease progression or intolerable toxicity. Dose reduction of QL1706 is not permitted.
Dacarbazine is administered intravenously as a 2-day regimen at a total dose of 850-1000 mg/m², divided over 2 consecutive days, every 3-4 weeks. During the combination phase, dacarbazine is administered intravenously on the day immediately following hepatic arterial infusion of QL1706 (i.e., day 1 after infusion). During the maintenance phase, dacarbazine is continued intravenously at the same dose and schedule until disease progression, intolerable toxicity, or discontinuation after 2 years of maintenance in patients without disease progression.
Lenvatinib is administered orally at a starting dose of 8 mg once daily. During the combination phase, lenvatinib is started on day 3 after hepatic arterial infusion of QL1706 and catheter removal. During the maintenance phase, lenvatinib is continued orally at the same dose until disease progression or intolerable toxicity, and is continued beyond 2 years after discontinuation of immunotherapy and chemotherapy in patients without disease progression.
Objective Response Rate (ORR)
ORR is defined as the proportion of patients whose best overall response is complete response (CR) or partial response (PR) according to RECIST v1.1, assessed by the investigator. Response evaluation is performed exclusively on pre-specified target lesions that are not subjected to cryoablation. For patients with both intrahepatic and extrahepatic metastases, extrahepatic target lesions are preferentially selected whenever feasible; for patients with intrahepatic lesions only, at least one measurable intrahepatic lesion is deliberately spared from ablation and serves as the target lesion for response assessment. Patients with a first documented CR or PR must have the response confirmed by repeat assessment at least 4 weeks later or at the next scheduled time point.
Time frame: From the initiation of study treatment until disease progression, death, or end of study, assessed up to 48 months.
Progression-Free Survival (PFS)
PFS is defined as the time from initiation of study treatment to the first documented disease progression on non-ablated target lesions per RECIST v1.1, as assessed by the investigator, or death from any cause, whichever occurs first.
Time frame: From initiation of study treatment to the first documented radiographic disease progression per RECIST v1.1, as assessed by the investigator, or death from any cause, whichever occurs first, assessed up to 48 months.
Overall Survival (OS)
OS is defined as the time from initiation of study treatment to death from any cause. Patients still alive at the time of analysis are censored at the date of last follow-up. Patients lost to follow-up are censored at the date of last confirmed survival.
Time frame: From the initiation of study treatment to death from any cause, assessed up to 48 months.
6-Month Progression-Free Survival Rate
The 6-month PFS rate is defined as the proportion of patients who are alive and free of disease progression on non-ablated target lesions per RECIST v1.1 at 6 months after initiation of study treatment, as assessed by the investigator.
Time frame: 6 months after initiation of study treatment.
Treatment-Related Adverse Events (TRAEs)
TRAEs are defined as adverse events judged by the investigator to be related to any component of the study treatment (cryoablation, hepatic arterial infusion of QL1706, intravenous dacarbazine, or oral lenvatinib). Adverse events are graded according to NCI-CTCAE v5.0, and the incidence, severity, and type of TRAEs and serious adverse events (SAEs) are recorded.
Time frame: From first dose until 30 days after the last dose of study treatment
Disease Control Rate (DCR)
DCR is defined as the proportion of patients whose best overall response is complete response (CR), partial response (PR), or stable disease (SD) lasting at least 6 weeks according to RECIST v1.1, as assessed by the investigator. Tumor response is assessed on all target lesions, but only non-ablated target lesions are used to determine the best overall response.
Time frame: From the initiation of study treatment until disease progression, death, or end of study, assessed up to 48 months.
Duration of Response (DoR)
DoR is defined as the time from the first documented objective response (CR or PR) on non-ablated target lesions to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first, as assessed by the investigator.
Time frame: From the first documented objective response (CR or PR) to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first, assessed up to 48 months.
Time to Progression (TTP)
TTP is defined as the time from initiation of study treatment to the first documented disease progression on non-ablated target lesions per RECIST v1.1, as assessed by the investigator. Deaths before documented progression are not counted as events for TTP.
Time frame: From the initiation of study treatment to the first documented disease progression per RECIST v1.1, as assessed by the investigator, assessed up to 48 months.
Plan to share: No — Individual participant data will not be shared because the informed consent does not explicitly permit data sharing with other researchers, and patient privacy and institutional data ownership policies apply. Only summary results will be published.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2028, 26 months later.
Of 278 non-industry phase 2 interventional studies under Melanoma, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 94. This study's planned 26 months is below that.
Counting every sponsor, half of 384 studies reached it within 53 months; a quarter within 32 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drugs tested here: Iparomlimab · Tuvonralimab · Lenvatinib