Actively Recruiting
Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen
Led by Sun Yat-sen University · Updated on 2024-06-13
82
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study comprises both Phase I and Phase II research. This phase focuses on safety, tolerability, and pharmacokinetics using a "3+3" dose escalation design with three dose groups: 1 mg/kg, 3 mg/kg, and 6 mg/kg. The drug will be administered in combination with the standard regimen for intermediate/high-risk rhabdomyosarcoma once every three weeks (Q3W). In phase II study, all subjects will receive Pucotenlimab combined with the standard regimen for intermediate/high-risk rhabdomyosarcoma for 2-4 cycles of neoadjuvant therapy every 3 weeks (Q3W), followed by surgery.
CONDITIONS
Official Title
Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 1 and 18 years old
- ECOG performance status score of 0 or 1
- Newly diagnosed intermediate or high-risk rhabdomyosarcoma confirmed by pathology
- Surgery evaluation indicates high difficulty
- At least one measurable tumor lesion by RECIST or WHO criteria
- Expected survival time of 6 months or more
- Cardiac function with LVEF 50%, no myocardial ischemia on EKG, and no arrhythmia needing treatment
- No history of severe immune-related side effects (Grade 3 or 4)
- For patients without bone marrow involvement: ANC 1.0 �������� 109/L, platelet count 100 �������� 109/L, hemoglobin 90 g/L
- Liver and kidney function within specified limits including bilirubin 2.5 times ULN, AST/ALT 2.5 times ULN, and estimated GFR 30 mL/min/1.73 m2
- Ability to comply with outpatient treatment, lab monitoring, and clinical visits
- Parents or guardians able to understand and sign informed consent, and participant able to express consent if applicable
You will not qualify if you...
- Previous treatment with anti-PD-1 or anti-PD-L1 antibodies or related drugs
- Prior chemotherapy, radiotherapy, or other treatments
- Previous surgery except biopsy
- Known allergy to PD-1 antibodies or severe allergies
- Other malignant tumors except cured cancers without recurrence for 3 years or certain skin cancers
- Active central nervous system metastases except stable asymptomatic brain metastases
- Uncontrolled pleural, pericardial effusions, or ascites requiring drainage
- Treatment toxicity above Grade 1 except alopecia or neurotoxicity
- History of mental disorders
- History of drug or substance abuse
- History of idiopathic pulmonary fibrosis or pneumonitis
- Comorbidities needing immunosuppressive drugs or corticosteroids at immunosuppressive doses
- History of autoimmune diseases except certain controlled conditions
- Active or past tuberculosis infection
- Active infections requiring systemic treatment
- Uncontrolled hypertension, pulmonary hypertension, unstable angina, recent heart events, severe arrhythmias, or recent cerebrovascular events
- Severe uncontrolled medical conditions like diabetes or bleeding
- Positive for HIV, syphilis, hepatitis C, or active hepatitis B
- Abnormal thyroid function tests
- Planning to receive live vaccines within 4 weeks before or 5 months after treatment
- Recent participation in another clinical trial with experimental drugs within 30 days before treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yizhuo Zhang
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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