Actively Recruiting
QL1706 Plus Lenvatinib in Previously Treated Penile Cancer
Led by Sun Yat-sen University · Updated on 2026-05-08
47
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II clinical study aims to evaluate the efficacy and safety of QL1706 in combination with lenvatinib in patients with previously treated advanced or metastatic penile squamous cell carcinoma. The primary objective of the study is to determine the median progression-free survival (PFS) of this regimen according to RECIST 1.1 criteria. Secondary objectives include evaluating objective response rate, disease control rate, overall survival, duration of response, safety, and the rate of conversion surgery. All enrolled participants will receive QL1706 plus lenvatinib as induction therapy for up to four treatment cycles (21 days per cycle). After completion of four cycles, tumor response will be assessed by imaging and multidisciplinary team (MDT) evaluation. Patients whose tumors become resectable and who are considered likely to benefit from surgery may undergo conversion surgery. Patients who are not eligible for surgery will continue study treatment. Following induction therapy or surgery, participants may continue QL1706 plus lenvatinib as continuation therapy. QL1706 will be administered for up to one year, and lenvatinib will be continued until disease progression according to RECIST 1.1, unacceptable toxicity, withdrawal of consent, or investigator decision. Tumor assessments will be performed using imaging studies such as CT or MRI at scheduled intervals. Safety will be monitored through clinical evaluations, laboratory testing, and adverse event reporting throughout the study.
CONDITIONS
Official Title
QL1706 Plus Lenvatinib in Previously Treated Penile Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Histologically or cytologically confirmed penile squamous cell carcinoma
- Previous treatment with chemotherapy, immunotherapy, and/or targeted therapy
- At least one measurable target lesion according to RECIST 1.1 criteria
- ECOG performance status score of 64 2
- Adequate bone marrow function with hemoglobin 65 75 g/L, white blood cell count 65 3.0x10^9/L, absolute neutrophil count 65 1.5x10^9/L, platelet count 65 100x10^9/L
- Adequate organ function: AST, ALT, ALP 64 2.5 times upper limit of normal; total bilirubin 64 1.5 times upper limit of normal; serum creatinine 64 1.5 times upper limit of normal
- Life expectancy of at least 12 months
- No significant history of severe cardiac, pulmonary, hepatic, or other major organ diseases
- Patient understands study procedures and provides written informed consent
You will not qualify if you...
- Participation in any investigational drug study within 4 weeks prior to treatment
- Active cancer other than penile squamous cell carcinoma or history of other malignancies within past 5 years except cured non-melanoma skin cancer, low-risk prostate cancer (T1a, Gleason score <6, PSA <0.5 ng/ml), superficial bladder cancer, or other solid tumors treated curatively with no recurrence for 5+ years
- Serious uncontrolled illnesses including recent severe cardiovascular, hepatic, respiratory, renal, hematological, endocrine, or neuropsychiatric events
- Active infection requiring antibiotics within 2 weeks prior to enrollment
- Congestive heart failure class III-IV
- Unstable angina or recent myocardial infarction within 6 months
- Untreated active Hepatitis B or C infection
- Administration of live vaccine within 30 days prior to first dose except injected inactivated influenza vaccine
- Immunodeficiency or recent systemic corticosteroid or other immunosuppressive therapy use
- History of HIV infection
- Recent use of Chinese herbal medicines with anti-tumor effects or immunomodulatory drugs
- Active autoimmune disease requiring systemic treatment within past 2 years
- Any other condition that may interfere with study participation or results as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
T
Ting Xue
CONTACT
K
Kangbo Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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