Phase II Study on Neoadjuvant Therapy of AK104 Combined With Nab-paclitaxel/Carboplatin in Fertility Preserving Surgery
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorXiaohua Wu
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
The histopathological types are small cell carcinoma, gastric adenocarcinoma, etc.
In addition to cervical cancer, subjects suffered from other malignant tumors within 3 years before enrollment. Subjects with other malignant tumors that have been cured by local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, breast cancer, etc., are not excluded.
Enroll in another clinical study at the same time, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study.
Patients with distant tumor metastasis or local and regional lymph node metastasis.
Trial design
Design model
Single group
Treatments tested in this trial
AK104
DrugAK104(10 mg/kg) d1,22
Carboplatin
DrugAUC=2 d1,8,15,22, 29, 36
Nab paclitaxel
Drug125mg／m2 d1,8,15,22,29,36
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Experimental: AK104 combined with nab-paclitaxel and carboplatinExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Adverse Events (AEs)
To evaluate the safety of AK104 combined with nab-paclitaxel and carboplatin in the neoadjuvant treatment of cervical cancer
Time frame
Up to approximately 6 mouths2
Tumor regression rate
The change of tumor size after the treatment,
Time frame
within 14 working days after operation3
Objective response rate
Objective response rate is the proportion of subjects with complete response(CR) or partial response(PR) , based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame
4-6 weeks after the second cycle(21 days per cycle) of neoadjuvant treatment4
The success rate of fertility sparing surgery
The rates of patients who can successfully preserve fertility.
Time frame
Up to approximately 6 mouthsSecondary outcomes
1
Major pathological response (MPR) rate
MPR rate is defined as the percentage of participants having ≤ 10% viable tumor cells in the pathological examination of resected specimens.
Time frame
within 14 working days after operation2
Pathological Complete Response (pCR) rate
pCR rate is defined as the percentage of participants lacking of evidence of viable tumor cells in the pathological examination of resected specimens.
Time frame
within 14 working days after operation3
Progression-free survival
Survival of patients
Time frame
Nearly 5 years after treatment4
Overall survival
Overall survival of patients
Time frame
Nearly 5 years after treatmentOther outcomes
1
Ratio of different immune cells in tumor micro-environment after neoadjuvant treatment
Biomarkers associated with efficacy of neoadjuvant immune-chemotherapy after the treatment
Time frame
Up to approximately 6 mouthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiaohua Wu
Lead sponsor
Fudan University
Sponsor institution
Source ClinicalTrials.gov