Phase II Study on Neoadjuvant Therapy of AK104 Combined With Nab-paclitaxel/Carboplatin in Fertility Preserving Surgery for Stage IB2-IB3 Cervical Cancer (FIGO 2018)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
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• 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.

• Subjects 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); ii. Platelet count ≥ 100 × 109/L (100,000/mm3); iii. Hemoglobin ≥ 90 g/L. b) Kidney: i. Calculated creatinine clearance\* (CrCl) ≥ 50 mL/min

• \* CrCl will be calculated using the Cockcroft-Gault formula (Cockcroft-Gault formula) CrCl (mL/min) = {(140 - age) × weight (kg) × 0.85}/ (serum creatinine. (mg/dL) × 72) ii .Urine protein \< 2+ or 24-hour (h) urine protein quantification \< 1.0 g.

• c) Liver: i. Serum total bilirubin (TBil) ≤ 1.5 × ULN ii. AST and ALT ≤ 2.5× ULN iii. Serum albumin (ALB) ≥ 28 g/L d) Coagulation function: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (e.g.

∙ If the subject is receiving anticoagulant therapy, the subject must receive a stable dose of anticoagulant and have coagulation during screening.

∙ Parameters (PT/INR and APTT) were within the expected range for anticoagulant therapy).

∙ e) Heart function: i. Left ventricular ejection fraction (LVEF) ≥ 50%.

• Female subjects 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 serum pregnancy test must be performed, and the serum pregnancy result shall prevail). and the result was negative. If a female subject of childbearing potential has sexual intercourse with a non-sterilized male partner, the subject must use an acceptable method of contraception since screening and must agree to continue using contraception methods for 120 days after the last dose of the study drug. Whether to discontinue contraception after this time point should be discussed with the investigator. Cyclic abstinence and safe period contraception are unacceptable methods of contraception.

‣ 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 is defined as at least one without alternative medical reasons). 12 consecutive months of amenorrhea and serum follicle-stimulating hormone levels within the laboratory reference range for postmenopausal women);

⁃ 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 highly effective. In addition to barrier contraceptive methods, female subjects of childbearing potential must also use hormonal contraceptive methods (such as birth control pills) alone to ensure that pregnancy does not occur.

• Subjects are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other requirements of the study.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Jin Li
fudanlijin@163.com
fudanlijin@163.com
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 30
Treatments
Experimental: Experimental: AK104 combined with nab-paclitaxel and carboplatin
Carboplatin, nab-paclitaxel and AK104 as neoadjuvant treatment before fertility-sparing surgery
Related Therapeutic Areas
Sponsors
Leads: Xiaohua Wu

This content was sourced from clinicaltrials.gov