The First Affiliated Hospital of Zhengzhou University
G UO under R UI
The purpose of this study is to evaluate the efficacy and safety of AK105 (anti-PD-1 mab) combined with Anlotinib Hydrochloride in the treatment of persistent, recurrent and metastatic cervical cancer.
Cervical Cancer
AK105 and anlotinib
Phase 2
Patients with persistent,recurrent or metastatic cervical cancer (histologic types include squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma) who had received at least once platinum-based systemic chemotherapy were enrolled.Eligible patients receive AK105 200 mg by intravenous (iv.) infusion every 3 weeks (Q3W),and anlotinib 12mg 2 weeks on/1 week off orally(Q3W).Imaging will be performed after the 3th AK105 administration as 3 cycles.This study is an open,single-arm,single-center clinical trial,and all the patients will receive AK105 and anlotinib treatment until radiographic progression,unacceptable toxicity, investigator or patient decision to withdraw, non-adherence to treatment or trial procedures.}}
Study Type : | Interventional |
Estimated Enrollment : | 36 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | A Single-center, Single-arm, Prospective Phase II Clinical Study of the Efficacy and Safety of AK105 Combined With Anlotinib in the Treatment of Persistent, Recurrent, and Metastatic Cervical Cancer |
Actual Study Start Date : | March 1, 2022 |
Estimated Primary Completion Date : | March 1, 2024 |
Estimated Study Completion Date : | September 1, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: AK105 and erlotinib AK105 200mg iv q3w;anlotinib 12mg 2w on/1w off po qd;21 days as a cycle until PD,intolerable toxicity, investigator or patient decision to withdraw, non-adherence to treatment or trial procedures. |
Drug: AK105 and anlotinib |
Ages Eligible for Study: | 18 Years to 75 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.