Cadonilimab (AK104) Plus Chemotherapy in Patients With Recurrent or Advanced Endometrial Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFujian Cancer Hospital
About this trial
This is an open-label, multi-center Phase II study of cadonilimab (AK104) combined with chemotherapy in patients with recurrent or advanced endometrial cancer. The primary objective is to evaluate objective response rate of cadonilimab plus chemotherapy.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
Patients must have had measurable stage III,IVA or recurrent endometrial cancer,and not suitable for curative radiotherapy or surgery.
All patients were required to have histologic confirmation of the original primary tumor (submission of pathology report(s) is required). Patients with the following histologic types were eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, mucinous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, carcinosarcoma, etc.
The subject has not received systematic chemotherapy in the advanced or recurrent disease, but is allowed to receive neoadjuvant therapy, adjuvant therapy (including chemotherapy, radiotherapy, or endocrine therapy) in the initial treatment stage, and the last adjuvant chemotherapy is required to be completed at least 6 months before enrollment. The final adjuvant radiotherapy, palliative radiotherapy (such as radiotherapy for bone metastases), and endocrine therapy should be completed at least 3 weeks before enrollment. For palliative radiotherapy of central nervous system (CNS) diseases, washout is allowed for one week.
Disqualifiers
Other malignant tumors in the past (within 5 years) or at the same time, excluding cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.) and breast cancer and thyroid cancer that have no recurrence more than 3 years after the completion of radical surgery.
Had received immunotherapy in the past, it includes immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.) , immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibody, etc.) , immune cell therapy, etc. Such subjects may be admitted with the consent of the sponsor.
Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Previous history of immunodeficiency; HIV antibody positive; Current long-term use of systemic corticosteroids or other immunosuppressants
Trial design
Treatments tested in this trial
- Cadonilimab
- Carboplatin
- Cisplatin
- Paclitaxel
Treatment groups
45 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Fujian Cancer Hospital
Lead sponsor
Fujian Provincial Hospital
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Zhangzhou Affiliated Hospital of Fujian Medical University
Collaborator
The First Affiliated Hospital of Bengbu Medical University
Collaborator
Source ClinicalTrials.gov