Actively Recruiting
RC48 in Combination With AK104 and Bevacizumab in OCCC
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-07-08
39
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Disitamab vedotin (RC48) in combination with AK104 (PD-1/CTLA-4 bispecific) and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer: a single-arm, phase II, multicenter study (DAB OCC study)
CONDITIONS
Official Title
RC48 in Combination With AK104 and Bevacizumab in OCCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological diagnosis of ovarian clear cell carcinoma or mixed carcinoma with at least 70% clear cell component and at least one evaluable lesion per RECIST 1.1
- HER2 IHC score of 1+ or higher
- Treatment-naive patients with tumor progression during postoperative chemotherapy or progression during/after platinum-containing neoadjuvant chemotherapy without surgery, with up to 2 prior chemotherapy lines
- Recurrent patients, platinum-sensitive or resistant, with no platinum-free interval of 6 months or more, who have received re-administration of platinum chemotherapy but cannot tolerate toxicity, with up to 2 chemotherapy lines post-recurrence
- Previous use of bevacizumab allowed
- Adequate bone marrow function: white blood cell count ≥3.0×10^9/L, neutrophil count ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥80 g/L
- Satisfactory organ function: AST ≤2.5× upper limit of normal, ALT ≤2.5× ULN, total bilirubin ≤1.5× ULN, creatinine ≤1.5× ULN
- ECOG performance status 0 or 1
- Voluntary informed consent provided
You will not qualify if you...
- Prior immunotherapy including PD-1, PD-L1, CAR-T, or CTLA-4 treatments
- Other malignancies diagnosed in past 5 years except skin or thyroid cancer
- Expected survival less than or equal to 12 weeks
- Known allergy to taxane-based medications
- Clinical contraindications to immunotherapy or bevacizumab such as uncontrolled infections, gastrointestinal fistula, autoimmune diseases, active hepatitis, or active bleeding
- Current treatment with investigational anti-cancer drugs in other clinical trials
- Any unstable condition that may risk patient safety or study adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital
Guanzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
J
Jing Li, doctor
CONTACT
M
Miaofang Wu, doctor
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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