NCT05137171

AK105 Combined With Anlotinib in Patients With Cervical Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	AK105 and anlotinib	AK105(penpulimab): 200mg, every 3 weeks, 21 days as a treatment cycle;Anlotinib: 12mg, 2 weeks on/1 week off, 21 days as a treatment cycle;Treatment will continue until confirmed radiographic progression,unacceptable toxicity, investigator or patient decision to withdraw, non-adherence to treatment or trial procedures.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-03-01
• Completion: 2024-09-01
• First posted: 2021-11-30
• Last updated: 2021-11-30