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New treatment option for Endometrial Neoplasms
Official title Cadonilimab With Chemoradiation for Recurrent and Oligometastatic Endometrial Carcinoma
ClinicalTrials.gov ID: NCT06532539
What this study is testing
What is Paclitaxel and Cisplatin?
Paclitaxel and Cisplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial neoplasms.
Also referred to as TP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate the efficacy and safety of cadonilimab in combination with paclitaxel, cisplatin, and radiation therapy for the treatment of locally recurrent and oligometastatic endometrial carcinoma. The main questions it aims to answer are: 1.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, women only
You may be able to join if
- A written informed consent form must be signed before the implementation of any trial-related procedures.
- Female, aged 18 years or older and 80 years or younger.
- ECOG PS 0-1.
- Newly diagnosed with histologically or cytologically confirmed primary endometrioid adenocarcinoma, serous carcinoma, clear cell adenocarcinoma...
- Patients with locally recurrent or oligometastatic endometrial cancer after initial treatment. The number of recurrent and metastatic lesions is ≤5...
You likely can't join if
- people with any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial lung...
- people currently using immunosuppressive agents or systemic, or absorbable local corticosteroid therapy to achieve immunosuppressive purposes (dose...
- Known history of grade 3 or 4 immune-related adverse events associated with previous anti-tumor immunotherapy.
- Poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA class II or higher heart failure; (2) unstable angina; (3) myocardial...
- Coagulation dysfunction (INR \>1.5 or PT \>16 s), bleeding tendency, or receiving thrombolytic or anticoagulant therapy.
- people who have received radiotherapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy within 4 weeks (or 5 drug half-lives...
See the full eligibility criteria
- A written informed consent form must be signed before the implementation of any trial-related procedures.
- Female, aged 18 years or older and 80 years or younger.
- ECOG PS 0-1.
- Newly diagnosed with histologically or cytologically confirmed primary endometrioid adenocarcinoma, serous carcinoma, clear cell adenocarcinoma, undifferentiated carcinoma, mixed cell adenocarcinoma, mesonephric...
- Patients with locally recurrent or oligometastatic endometrial cancer after initial treatment. The number of recurrent and metastatic lesions is ≤5. Screening criteria for oligometastasis: lymph node metastases in the...
- At least one site suitable for radiotherapy (including the primary lesion), measurable, and meeting the RECIST v1.1 criteria for evaluable lesions.
- Tumor samples available for biomarker assessment.
- Expected survival time ≥6 months.
- Normal major organ function (within 7 days before enrollment), meeting the following criteria: (1) Hematology standards (without blood transfusion or hematopoietic growth factor treatment within 14 days before...
- Hemoglobin (HB) ≥80 g/L;
- Absolute neutrophil count (ANC) ≥1.5×10\^9/L;
- Platelet count (PLT) ≥50×10\^9/L; (2) No functional or organic diseases, meeting the following criteria: a) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, total serum bilirubin ≤1.5×ULN...
- people with any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial lung disease, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis...
- people currently using immunosuppressive agents or systemic, or absorbable local corticosteroid therapy to achieve immunosuppressive purposes (dose \>10 mg/day prednisone or equivalent) and continuing use within 2 weeks...
- Known history of grade 3 or 4 immune-related adverse events associated with previous anti-tumor immunotherapy.
- Poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within the past six months; (4) clinically significant...
- Coagulation dysfunction (INR \>1.5 or PT \>16 s), bleeding tendency, or receiving thrombolytic or anticoagulant therapy.
- people who have received radiotherapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy within 4 weeks (or 5 drug half-lives, whichever is longer) prior to the first dose of the study drug; people...
- people with clinically uncontrolled third-space effusion requiring puncture drainage or other local treatment prior to the first dose of the investigational drug.
- people with significant hemoptysis within 2 months before randomization, or hemoptysis of at least half a teaspoon (2.5 ml) per day.
- Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism).
- people with active infection or unexplained fever \>38.5°C during the screening period or prior to the first dose.
- people with a history of or current evidence of lung fibrosis, interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired lung function.
- people with congenital or acquired immune deficiencies (e.g., HIV infection) or active hepatitis (hepatitis B reference: HBV DNA exceeding the upper limit of normal; hepatitis C reference: HCV viral load or RNA...
- people who have used other investigational drugs or similar therapeutic agents within 4 weeks prior to the first dose or who have received radiotherapy or other local treatments within 2 weeks prior to the first dose...
- people with a history of or concurrent other malignancies (excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ).
- people who may receive other systemic anti-tumor therapies during the study period.
- people who have received or are expected to receive live vaccines within 4 weeks prior to the first dose or during the study period.
- people with other factors that may lead to forced termination of the study as judged by the investigator, such as severe diseases (including mental disorders) requiring combined treatment, severe laboratory...
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.