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New treatment option for Neoadjuvant Immunotherapy
Official title Phase II Study on Neoadjuvant Therapy of AK104 Combined With Nab-paclitaxel/Carboplatin in Fertility Preserving Surgery
ClinicalTrials.gov ID: NCT06209294
What this study is testing
What is AK104?
AK104 is an investigational medicine, being studied as a potential treatment for neoadjuvant immunotherapy.
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
- This is a Phase II study of neoadjuvant therapy of AK104 combined with nab-paclitaxel/carboplatin in fertility saving surgery for stage IB2-IB3 cervical cancer (FIGO 2018). The main questions it aims to answer are: Evaluate the safety of AK104 combined with nab-paclitaxel/carboplatin in the neoadjuvant treatment of cervical cancer Evaluate the tumor regression and Major Pathological Response(MPR) of AK104 combined with nab-paclitaxel/carboplatin as neoadjuvant therapy for cervical 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 45, women only
You may be able to join if
- Voluntarily sign a written ICF.
- Age ≥ 18 years old and ≤ 45 years old at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Patients with histologically confirmed (2018 FIGO) stage IB2-IB3 cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma.
- Imaging evaluation showed no distant metastasis or regional lymph node metastasis, and the tumor was limited to the cervix.
You likely can't join if
- The histopathological types are small cell carcinoma, gastric adenocarcinoma, etc.
- In addition to cervical cancer, people suffered from other malignant tumors within 3 years before enrollment. people with other malignant tumors that...
- Enroll in another clinical study at the same time, unless it is an observational, non-treatment clinical study or the follow-up period of an...
- Patients with distant tumor metastasis or local and regional lymph node metastasis.
- Patients who received non-specific immunomodulatory therapy (such as interleukins, interferons, thymosin, tumor necrosis factor, etc., excluding...
- Suffering from active autoimmune diseases that require systemic treatment (such as disease-modifying drugs, corticosteroids, immunosuppressive...
See the full eligibility criteria
Who can join
- Voluntarily sign a written ICF.
- Age ≥ 18 years old and ≤ 45 years old at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Patients with histologically confirmed (2018 FIGO) stage IB2-IB3 cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma.
- Imaging evaluation showed no distant metastasis or regional lymph node metastasis, and the tumor was limited to the cervix.
- Have not received any systemic or local anti-tumor treatment for cervical cancer before the first medication, including radiotherapy, chemotherapy, immunotherapy, biological agents, small molecule targeted therapy, etc.
- Patients who require preservation of reproductive function and who are judged by the researcher to have no contraindications to childbirth surgery.
- At least 1 untreated measurable lesion according to RECIST v1.1.
- people agree to collect tumor tissue and peripheral blood samples required during the screening period and research process and use them in related research.
- With good organ function: a) Hematology (no blood components and cell growth factor support therapy were used within 7 days before starting study treatment): i. Absolute neutrophil count ANC ≥ 1.5 × 109/L (1,500/mm3)...
- Female people with childbearing potential must undergo a urine or serum pregnancy test within 3 days before taking the drug for the first time (if the urine pregnancy test result cannot be confirmed to be negative, a...
- Women of childbearing potential are those who have not been surgically sterilized (i.e., bilateral fallopian tube ligation, bilateral oophorectomy, or total hysterectomy) or who have not undergone menopause (menopause...
- Highly effective contraceptive methods refer to contraceptive methods that have a very low contraceptive failure rate (e.g. less than 1% per year) when used correctly and consistently. Not all birth control methods are...
- people are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other requirements of the study.
What rules you out
- The histopathological types are small cell carcinoma, gastric adenocarcinoma, etc.
- In addition to cervical cancer, people suffered from other malignant tumors within 3 years before enrollment. people with other malignant tumors that have been cured by local treatment, such as basal or cutaneous...
- Enroll in another clinical study at the same time, unless it is an observational, non-treatment clinical study or the follow-up period of an treatment study.
- Patients with distant tumor metastasis or local and regional lymph node metastasis.
- Patients who received non-specific immunomodulatory therapy (such as interleukins, interferons, thymosin, tumor necrosis factor, etc., excluding IL-11 used to treat thrombocytopenia) within 2 weeks before the first...
- Suffering from active autoimmune diseases that require systemic treatment (such as disease-modifying drugs, corticosteroids, immunosuppressive treatment), Replacement therapy (eg, thyroxine, insulin, or physiologic...
- Patients have a history of non-infectious pneumonia or pneumonia requiring systemic glucocorticoid treatment or a current history of interstitial lung disease.
- With a history of severe bleeding tendency or coagulation disorder.
- Patients with currently uncontrolled comorbid diseases, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or a...
- Patients with history of myocarditis, cardiomyopathy, and malignant arrhythmia. Patients suffered unstable angina, congestive heart failure or vascular disease requiring hospitalization (such as aortic aneurysm or...
- Patients with active or clear history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis or chronic diarrhea).
- Patients with serious infection occurring within 4 weeks before the first dose, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia; Patients with active infection (excluding...
- Patients suffered major surgery or serious trauma within 30 days before the first medication; or minor local surgery within 3 days before the first medication (excluding central venous catheterization via peripheral...
- Patients with a history of immunodeficiency; those with positive HIV antibody test; Patients who are taking long-term systemic corticosteroids or other immunosuppressants.
- people who are known to have active pulmonary tuberculosis (TB) and are suspected of having active TB need to undergo clinical examination to exclude (such as sputum tuberculosis bacilli examination, chest X-ray, etc.)...
- Patients with history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- people with untreated active hepatitis B (HBsAg positive and HBV-DNA exceeding 1000 copies/ml (200 IU/ml) or higher than the lower limit of detection).people with hepatitis B are required to receive anti-hepatitis B...
- Patients who have received a live vaccine within 30 days before the first dose, or plan to receive a live vaccine during the study.
- Patients who are hypersensitive to any component of any study drug; with history of severe hypersensitivity reactions to other monoclonal antibodies.
- Patients with history of mental illness, substance abuse, alcoholism, or drug abuse.
- Pregnant or lactating women.
- Patients with any past or current disease, treatment, or laboratory test abnormality may confuse the research results and affect the subject's full participation in the research, or participation in the research may not...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.