New drug combo may help save kidneys in High-Risk cancer patients
NCT ID NCT07386158
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving two drugs (pucotenlimab and vorolanib) before surgery can shrink kidney tumors enough to allow partial kidney removal instead of full removal. It includes 21 adults with high-risk clear cell renal cancer who need surgery but have tumors that make kidney-sparing surgery difficult. The goal is to see how many patients respond to the drugs and safely undergo partial nephrectomy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 21 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2025
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily sign a written informed consent form (ICF). 2. Age at the time of enrollment is between 18 years old and 85 years old, regardless of gender. 3. The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1. 4. Expected survival period ≥ 3 months. 5. Preoperative biopsy pathology confirms renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma 6. ECOG score 0 or 1 7. The patient is willing to undergo kidney preservation surgery 8. Preoperative assessment of healthy kidney GFR\<60 ml/min through renal dynamic imaging 9. There are indications for kidney preservation surgery, but the surgery is difficult \[① 4-7cm tumor located at the renal hilum or endogenous ≥ 75% (T1bN0M0); ② Tumors larger than 7cm (T2N0M0)\] 9. There should be at least one measurable lesion (according to mRECIST v1.1 criteria) that is suitable for repeated and accurate measurements. 10. Good organ function, laboratory test results during the screening period meet the following criteria: <!-- --> 1. Hematology (no blood components or cell growth factors are allowed to support treatment within 2 weeks before starting treatment): a. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/mm3); b. Platelet count (PLT) ≥ 100 × 109/L (100000/mm3); c. Hemoglobin (HB) ≥ 90 g/L; 2. Liver: 1. Serum total bilirubin (TBIL) ≤ 1.5 × ULN; 2. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT ≤ 5 × ULN 3. Serum albumin (ALB) ≥ 28g/L 3. Coagulation function: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN 11. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study. Exclusion Criteria: • Renal vein cancer thrombus • Diffuse tumor growth, with no clear boundary from normal renal parenchyma • General poor condition, anesthesia assessment cannot tolerate general anesthesia surgery • Have serious cardiovascular and cerebrovascular diseases, uncontrollable • hypertension and diabetes • Patients who have long-term use of immunosuppressants after organ transplantation • Patients who are currently using immunosuppressive drugs • Patients with clear infection or fever • Patients with T-cell lymphoma and myeloma • Patients who have concurrent malignant tumors, are currently undergoing treatment for other benign or malignant tumors, or have a history of other malignant tumors within the past six months • Metastatic renal cell carcinoma. • Received Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications within 14 days prior to the first use of the investigational drug • Perform systematic treatment (including thymosin, interferon, interleukin, except for local use to control pleural effusion). • Suffering from active or potentially recurrent autoimmune diseases, except for vitiligo, hair loss, psoriasis, or eczema that do not require systemic treatment; Hypothyroidism caused by autoimmune thyroiditis only requires stable doses of hormone replacement therapy; Type I diabetes requiring only a stable dose of insulin replacement therapy. • Simultaneously enrolled in another clinical study, unless it is an observational, non interventional clinical study or a follow-up period of an interventional study. Known history of mental illness, drug abuse, alcoholism, or drug use. * Pregnant or lactating women. * Any past or current illness, treatment, or laboratory test abnormalities may confuse the research results, affect the full participation of the subjects in the study, or participation in the study may not be in the best interests of the subjects.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Clear cell renal cell carcinoma (CCRCC) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Other (Non U.s.), 0755, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive tracer aims to spot kidney cancer with sharper eyes
- Can an oral HER2 drug boost Chemo's punch in HER2-Low breast cancer?
- Breast Cancer's genetic fingerprint: a new platform aims to match tumors to targeted trials
- Can immunotherapy before surgery shrink head and neck tumors?
- Can a Triple-Drug combo before surgery eliminate EGFR-Mutant lung cancer?
- MRI 'Fingerprint' may reveal which head and neck tumors vanish with Pre-Surgery therapy