Clinical trial · Interventional
Anlotinib and Niraparib Dual Therapy Evaluation in Platinum-resistant Recurrent Ovarian Cancer
An Open-label, Single Arm, Phase II Trial of Niraparib in Combination With Anlotinib in Patients With Platinum-resistant Recurrent Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer (Ovarian Cancer)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
At present, the standard treatment for platinum-resistant ovarian cancer patients is platinum-free chemotherapy, with poor efficacy and tolerance. The combination of anti-angiogenic drugs and PARPi can play a synergistic anti-tumor role and achieve good efficacy in platinum-sensitive recurrent ovarian cancer. This study intends to explore the safety and effectiveness of anlotinib and niraparib dual therapy in patients with platinum-resistant recurrent ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (ovarian cancer).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Platinum-resistant Ovarian Cancer | Platinum-Resistant Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
| Niraparib | Drug | Niraparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- Niraparib 300mg(Body Weigh ≥77 kg)/200mg (Body Weigh \<77 kg) po QD day1\~21, Anlotinib 12mg po QD day1\~14. Starting dose of anlotinib changed to 10mg from 2020-11-13.
- interventionNames
- Drug: Niraparib
- Drug: Anlotinib
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- at 6 months
- description
- The primary objective of this study is to determine the preliminary efficacy of administration of niraparib in combination with anlotinib in the treatment of platinum-resistant recurrent ovarian cancer, as measured by the objective response rate (ORR), which is a combination of CR (the target lesion completely disappeared over 4 weeks) and PR (Target lesions were reduced by more than 30% for more than 4 weeks).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Subjects understand the trial process, sign informed consent, agree to participate in the study, and have the ability to follow the protocol; 2. 18 \~ 70 years old (inclusive), female; 3. Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer; 4. Subjects were initially treated with platinum, and the disease recurrence occurred within 6 months after the end of the previous platinum-containing chemotherapy, that is, platinum resistance relapsed; 5. Life expectancy \> 16 weeks; 6. Patient's ECOG physical status score is 0-1; 7. Subject agrees to take blood samples for gBRCA mutations; 8. Can provide formalin-fixed, paraffin-embedded tumor tissue samples for sBRCA and homologous recombination repair-related genes detection (optional); 9. Good organ function, including: * Neutrophil count \>= 1500 / μL; * Platelets \>= 100,000 / μL; * Hemoglobin \>= 9g / dL; * Serum creatinine \<= 1.5 times the upper limit of normal value, or creatinine clearance \>= 60mL / min (calculated according to Cockcroft-Gault formula); * Total bilirubin \<= 1.5 times the upper limit of normal value or direct bilirubin \<= 1.0 times the upper limit of normal value; * AST and ALT \<= 2.5 times the upper limit of normal value. When liver metastases are present, it must be \<= 5 times the upper limit of normal value. 10\. The toxic side effects of any previous chemotherapy have recovered to \<= CTCAE level 1 or baseline levels, except for sensory neuropathy or hair loss with stable symptoms \<= CTCAE level 2. Exclusion Criteria: 1. People who are known to be allergic to Niraparib or Anlotinib (or active or inactive ingredients of drugs with similar chemical structure); 2. Symptomatic, uncontrolled brain or pia mater metastases; 3. Underwent major surgery within 3 weeks before the study began or has not recovered after surgery; 4. Received palliative radiotherapy of \> 20% bone marrow 1 week before enrollment; 5. Have invasive cancer other than ovarian cancer (except fully treated basal or squamous cell skin cancer) within 2 years before enrollment; 6. Patients with central lung squamous cell carcinoma or at risk for large hemoptysis; 7. Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 8. Severe or uncontrolled diseases, including but not limited to: uncontrollable nausea and vomiting, inability to swallow or gastrointestinal diseases that may interfere with drug absorption and metabolism; active viral infections; mental illnesses that affect patients' signed informed consent History of bleeding tendency and thrombosis; history of severe cardiovascular disease; 9. Laboratory abnormalities: hyponatremia; hypokalemia; uncontrollable nail function abnormalities; 10. Receive platelet or red blood cell transfusions within 4 weeks; 11. Patients who are pregnant or nursing, or who plan to become pregnant during study treatment; 12. Have previously received any PARP inhibitor treatment.
References
Publications (2)
- DERIVEDDeng T, Yan L, Li J, Liu G, Yin A, Feng Y, Zheng M, Zhang C, Huang H, Huang Q, Lin A, Jiang J, Kong B, Liu J. Adverse Event Management in Patients with Platinum-Resistant Ovarian Cancer Treated with Niraparib and Anlotinib: Updates from the Phase II, Multi-Center ANNIE Study. Ther Clin Risk Manag. 2025 Jul 21;21:1135-1147. doi: 10.2147/TCRM.S526755. eCollection 2025. PMID 40718116
- DERIVEDLiu G, Feng Y, Li J, Deng T, Yin A, Yan L, Zheng M, Xiong Y, Li J, Huang Y, Zhang C, Huang H, Wan T, Huang Q, Lin A, Jiang J, Kong B, Liu J. A novel combination of niraparib and anlotinib in platinum-resistant ovarian cancer: Efficacy and safety results from the phase II, multi-center ANNIE study. EClinicalMedicine. 2022 Nov 30;54:101767. doi: 10.1016/j.eclinm.2022.101767. eCollection 2022 Dec. PMID 36583171