A Prospective, Single-Arm, Multicenter Clinical Study of High-Risk Localized and Locally Advanced… (NCT07741617) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Prospective, Single-Arm, Multicenter Clinical Study of High-Risk Localized and Locally Advanced Renal Clear Cell Carcinoma
China54 participantsStarted 2026-08-15
Plain-language summary
Study Design Prospective, single-arm, multicenter clinical study.
Study Drugs
Neoadjuvant phase: QL1706 (Aipaluo Tuoworilimab, an anti-PD-1/CTLA-4 combination antibody) plus lenvatinib.
Adjuvant phase: QL1706 monotherapy.
Target Population Patients with high-risk localized or locally advanced clear cell renal cell carcinoma (ccRCC) meeting AJCC staging criteria (e.g., cT3a G3-4 cN0M0, etc.) who are candidates for neoadjuvant therapy and surgical resection.
Treatment Flow
Screening (28 days): Informed consent obtained, baseline assessments completed.
Neoadjuvant phase (4 cycles, 21 days/cycle):
QL1706 5 mg/kg IV, Q3W; plus oral lenvatinib 12 mg QD.
Efficacy evaluation every 2 cycles; surgery after 4 cycles (unless early termination).
Adjuvant phase (13-17 cycles, 21 days/cycle):
Eligible patients continue QL1706 5 mg/kg IV, Q3W.
Imaging every 3 months until recurrence, new therapy, death, or completion of 21 cycles total.
Follow-up: Safety follow-up (90 days after last QL1706 dose or 30 days after last other drug, whichever is longer), then survival follow-up every 90 days.
Endpoints
Primary: Objective response rate (ORR) per RECIST 1.1.
Secondary: Pathological complete response rate (pCR), median disease-free survival (mDFS), 12-/24-month DFS rates, median overall survival (mOS), and safety.
Sample Size Planned enrollment: 54 subjects.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability to understand and agree to comply with the study requirements and assessment schedule, and voluntarily provide written informed consent (ICF) prior to any trial-related procedures.
. Age ≥ 18 years and ≤ 75 years, male or female.
. Histologically or cytologically confirmed localized and locally advanced clear cell renal cell carcinoma.
. Locally advanced renal cell carcinoma (stage III per AJCC): cT3a G3-4 cN0 M0; cT3b-T4 Gany cN0 M0; cTany cN1 Gany cM0; or high-risk localized renal cell carcinoma: cT1b G4 or with sarcomatoid features cN0 cM0; cT2 G3-4 cN0 cM0.
. No prior treatment with any immune checkpoint inhibitor.
. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate(ORR)
Timeframe: every 6 weeks to 2 years assessed by the investigator per RECIST v1.1.
Trial details
NCT IDNCT07741617
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
. At least one measurable lesion according to RECIST v1.1.
Exclusion criteria
. Presence of symptomatic or untreated known brain metastases or other central nervous system (CNS) metastases. CNS metastases that have been completely resected and/or irradiated with documented stability or improvement are not exclusionary, provided that computed tomography (CT) shows stability for at least 4 weeks prior to screening, with no evidence of cerebral edema and no requirement for glucocorticoids or anticonvulsants
. Patients with advanced or metastatic renal cell carcinoma, or non-clear cell renal cell carcinoma
. Known hypersensitivity to the investigational product or any of its excipients; or previous allergy to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
. Prior discontinuation of immunotherapy due to severe and/or life-threatening immune-related adverse events
. Adverse events from prior anti-tumor therapy have not recovered to ≤ Grade 1 per NCI-CTCAE v5.0 at enrollment (except for alopecia or other toxicities deemed by the investigator to be tolerable and not clinically significant)
. Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients on hormone replacement therapy may be considered for inclusion); patients with psoriasis or childhood asthma/allergy that has completely resolved and requires no intervention in adulthood may be considered, but those requiring bronchodilators for medical intervention are excluded
. History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.
. Presence of poorly controlled cardiac symptoms or diseases, including but not limited to: heart failure ≥ NYHA class II, unstable angina, myocardial infarction within 1 year, and clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or remain poorly controlled after intervention