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
Qualifiers
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
Treatments tested in this trial
- AK104
- Carboplatin
- Nab paclitaxel
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Xiaohua Wu
Lead sponsor
Fudan University
Sponsor institution
Source ClinicalTrials.gov