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Tests treatment safety and results for Endometrioid Endometrial Cancer
Official title Clinical Efficacy Study of PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Advanced Endometrial Cancer
ClinicalTrials.gov ID: NCT06561308
What this study is testing
What is Camrelizumab?
Camrelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrioid endometrial cancer.
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
- Exploring the therapeutic effect of neoadjuvant chemotherapy combined with PD-1 inhibitor camrelizumab on advanced stage III-IV endometrial cancer
- 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 75, women only
You may be able to join if
- Endometrial cancer initially diagnosed as stage III non-operable resectable, stage IV (FIGO, 2009 criteria) after imaging evaluation
- Pathologically confirmed endometrial cancer that looks like endometrial carcinoma
- Patient age ≥18 years and ≤75 years old
- ECOG status score of 0-1
- tolerate surgery and radiotherapy
You likely can't join if
- people with an active, known, or suspected autoimmune disease, or a history of an autoimmune disease, except for: vitiligo, alopecia areata, Graves'...
- Prior treatment with immune checkpoint inhibitors, including, but not limited to, other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or any...
- Known hypersensitivity to any component and/or any excipient of the trial regimen;
- Immunosuppressive drugs or systemic corticosteroids for immunosuppression (\>10 mg/day of prednisone or other equivalent) within 2 weeks prior to...
- Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2) within 2 weeks prior to the...
- Active systemic infection requiring systemic treatment;
See the full eligibility criteria
- Endometrial cancer initially diagnosed as stage III non-operable resectable, stage IV (FIGO, 2009 criteria) after imaging evaluation
- Pathologically confirmed endometrial cancer that looks like endometrial carcinoma
- Patient age ≥18 years and ≤75 years old
- ECOG status score of 0-1
- tolerate surgery and radiotherapy
- Laboratory tests: WBC ≥3.5×109/L, NEU ≥1.5×109/L, PLT ≥80×109/L, serum ≥80×109/L, serum ≥80×109/L, serum ≥80×109/L, serum ≥80×109/L. ×109/L, serum bilirubin ≤1.5 times the high limit of normal value, transaminase ≤1.5...
- Able to follow up and good compliance;
- Able to sign the informed consent form, including compliance with the requirements and restrictions listed in the informed consent form and the program.
- people with an active, known, or suspected autoimmune disease, or a history of an autoimmune disease, except for: vitiligo, alopecia areata, Graves' disease, psoriasis, or eczema that has not required systemic therapy...
- Prior treatment with immune checkpoint inhibitors, including, but not limited to, other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or any treatment directed against immune co-stimulators (e.g., antibodies...
- Known hypersensitivity to any component and/or any excipient of the trial regimen;
- Immunosuppressive drugs or systemic corticosteroids for immunosuppression (\>10 mg/day of prednisone or other equivalent) within 2 weeks prior to trial dosing; topical, ophthalmic, intra-articular, intranasal, and...
- Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2) within 2 weeks prior to the trial;
- Active systemic infection requiring systemic treatment;
- Serious infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;
- Patients with untreated chronic hepatitis B, or HBV carriers with chronic hepatitis B virus (HBV) DNA greater than 1,000 IU/mL, or patients with active hepatitis C. Inactive HBsAg carriers, treated hepatitis B patients...
- Known active tuberculosis (TB), patients with suspected active TB should undergo chest X-ray and sputum examination in conjunction with clinical signs and symptoms for exclusion;
- Immunodeficiency or human immunodeficiency virus (HIV antibody positive);
- people with active inflammatory bowel disease or a history of such disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea). people who are unable to swallow or who have malabsorption syndrome...
- Known interstitial lung disease that is symptomatic or may interfere with detection or treatment of immune-associated pneumonia;
- Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first trial dose, inactivated seasonal influenza virus vaccine is permitted;
- Patients who have received a prior allogeneic bone marrow transplant or solid organ transplant;
- History of primary malignant tumor within the last 5 years;
- people who have undergone major surgery (e.g., open abdomen, open chest, organ resection, etc.) and severe trauma within 28 days prior to the first dose of implantable infusion devices are permitted;
- people with a history of gastrointestinal perforation, gastrointestinal fistula, or female genital fistula;
- Uncontrolled other co-morbidities, symptoms, or medical history, including: (1) Persons with one of the following cardiovascular diseases or cardiovascular risk factors: myocardial infarction, unstable angina pectoris...
- Female patients who are pregnant or breastfeeding; women of childbearing age who refuse to accept contraceptive measures during neoadjuvant immunotherapy;
- Concurrent participation in other treatment clinical trials; participation in observational and non-treatment clinical trials is permitted;
- Any condition that, in the opinion of the Investigator, may result in risk in the receipt of the study drug or that would interfere with the evaluation of the safety of the study drug or the interpretation of the study...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.