Clinical trial · Interventional
Bevacizumab Plus Modiifed FOLFIRINOX in Ovarian, Fallopian Tube, or Primary Peritoneal Mucinous Carcinoma
Single-arm Phase II Study of Bevacizumab Plus Modified FOLFIRINOX Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Mucinous Carcinoma
NCT05665023CI-TRIAL-00062932unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This research study is evaluating a modified FOLFIRINOX plus bevacizumab therapy for mucinous ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Mucinous Ovarian Cancer | Ovarian Mucinous Tumor | ALIAS | 0.90 |
| Primary Peritoneal Cancer | Fallopian Tube Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab + modified FOLFIRINOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab + modified FOLFIRINOX
- description
- Bevacizumab 5mg/kg D1, oxaliplatin 85 mg/m2 D1 + leucovorin 400mg/m2 D1 + irinotecan 150 mg/m2 D1 + 5-FU 2,400 mg/m2 46h continuous infusion, every other week
- interventionNames
- Drug: Bevacizumab + modified FOLFIRINOX
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- up to 1 year
- description
- Objective response rate assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for Intention-to-treatment group
Secondary outcomes (7)
- measure
- Progression-free survival
- timeFrame
- up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with recurrent, metastatic, or unresectable ovarian cancer, fallopian tube cancer, or primary peritoneal cancer diagnosed cytologically or histologically as mucinous cancer. \*Subjects who are metastatic (stage IV) or mucinous ovarian cancer that cannot be surgically resected at diagnosis may have undergone cytoreductive surgery prior to systemic chemotherapy. It is appropriate for participation in this study if there are residual lesions after surgery and other selection criteria are met. 2. Mucous tumors of gastrointestinal origin should be excluded by prior upper and lower intestinal endoscopy and pathologic immunohistochemical staining (CEA, SATB2, etc.). 3. Patients who have not received previous systemic chemotherapy for recurrent, metastatic, or unresectable ovarian, fallopian tube, or primary peritoneal cancer, or who have failed second-line or less systemic chemotherapy. However, immunotherapy alone (eg, anti-PD-1 or anti-PD-L1 immunotherapy) is not included in previous chemotherapy. \*Platinum susceptibility does not affect the selection/exclusion criteria for this trial. 4. Informed consent 5. Age more than 19 years old 6. Patients with measurable lesions according to RECIST v1.1. 7. ECOG Performance score 0-2 8. Patients with adequate organ function 9. Women of childbearing potential must either have a negative pregnancy test on a urine or serological test or consent to the use of an appropriate contraceptive method. Exclusion Criteria: 1. Patients who have previously received systemic chemotherapy, including oxaliplatin or irinotecan. \*Previous treatment with bevacizumab is acceptable. 2. Pregnant or breastfeeding women 3. Patients who received chemotherapy, targeted small-molecule agents, or radiotherapy within 2 weeks prior to Day 1 of the study, or who have not yet recovered (Grade 1 or lower or baseline level) from a previously administered drug-induced adverse event. 4. Active central nervous system (CNS) metastases and/or carcinoma meningitis. 5. Patients with known aggravation within the past 3 years or other malignant tumors requiring aggressive treatment. 6. Patients with moderate acute or chronic medical conditions or abnormal findings on examination, which are judged to affect the results of this study 7. Infected with Human Immunodeficiency Virus (HIV) (HIV-1/2 antibody) infection or active hepatitis B (HBsAg positive and HBV DNA ≥100 copies/ml) or hepatitis C (anti-HCV antibody positive and HCV RNA detected) being) 8. Clinically significant heart disease.
References
Publications (0)
Data not yet available
No reference posted for this study.