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New treatment option for Vorolanib
Official title Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC
ClinicalTrials.gov ID: NCT07386158
What this study is testing
What is Pucotenlimab combination with Vorolanib?
Pucotenlimab combination with Vorolanib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for vorolanib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Through the neoadjuvant treatment with a combination of Pucotenlimab and Vorolanib, it enabled the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who had indications for nephron-sparing surgery but faced considerable difficulty in preserving the kidney (T1b with an endophytic component ≥75% or T2)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Voluntarily sign a written informed consent form (ICF).
- Age at the time of enrollment is between 18 years old and 85 years old, regardless of gender.
- The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1.
- Expected survival period ≥ 3 months.
- Preoperative biopsy pathology confirms renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma
You likely can't join if
- 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
See the full eligibility criteria
- Voluntarily sign a written informed consent form (ICF).
- Age at the time of enrollment is between 18 years old and 85 years old, regardless of gender.
- The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1.
- Expected survival period ≥ 3 months.
- Preoperative biopsy pathology confirms renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma
- ECOG score 0 or 1
- The patient is willing to undergo kidney preservation surgery
- Preoperative assessment of healthy kidney GFR\<60 ml/min through renal dynamic imaging
- 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...
- Good organ function, laboratory test results during the screening period meet the following criteria:
- 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) ≥...
- Liver:
- Serum total bilirubin (TBIL) ≤ 1.5 × ULN;
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × ULN; For people with liver metastasis, AST and ALT ≤ 5 × ULN
- Serum albumin (ALB) ≥ 28g/L
- Coagulation function: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN 11. The people are willing and able to comply with the scheduled visits, treatment plans...
- 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...
- Simultaneously enrolled in another clinical study, unless it is an observational, non treatment clinical study or a follow-up period of an treatment study. Known history of mental illness, drug abuse, alcoholism, or...
- 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 people in the study, or participation in the study may not be in the best...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Other (Non U.s.), China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Other (Non U.s.), China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.