Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas

Chemotherapy Clinical Trial

Official title:

Anti-PD-1 Antibody Camrelizumab Combined With Cisplatin/Paclitaxel/Bevacizumab for Recurrent or Advanced Cervical Neuroendocrine Carcinomas: A Single Arm, Phase II Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04635956
• Other study ID #: CNET-PD1
• Status: Recruiting
• Phase: Phase 2
• Start date: November 15, 2020
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2020
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, M.D.
• Phone: +86-139-1198-8831
• Email: lilleigh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recurrent or advanced cervical neuroendocrine carcinoma (NEC) is refractory to multimodal treatment, even to extensive therapy. Chemotherapy, consisting of platinum and etoposide, remains the main therapy for recurrent or advanced cervical NEC. In addition, bevacizumab has shown progression-free benefits in recurrent or advanced cervical cancer. Case report suggested anti-PD-1 antibody may have antitumor activities in NEC. Based on these evidences, a phase 2, single arm trial is conducted to explore the objective response rate (ORR) of platinum/etoposide/bevacizumab/anti-PD-1 antibody (camrelizumab) for the treatment of recurrent or advanced cervical NEC. This trial is to enroll 20 patients, who would accept 6 courses of platinum/etoposide/bevacizumab/camrelizumab. If the patient achieved complete or partial remission, a total period of 12 months bevacizumab/camrelizumab will be given as maintain therapy. The primary endpoint is ORR. The second endpoints are severe adverse events according to criteria of Common Terminology Criteria for Adverse Events (CTCAE) and iRECIST Guideline, and critical changes of laboratory testing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed recurrent or advanced cervical neuroendocrine carcinoma

• Aged 18 years or older

• No immunosuppressive disease

• Signed an approved informed consents

• Performance status of ECOG 0-1

Exclusion Criteria:

• Not meeting all of the inclusion criteria

Related Conditions & MeSH terms

• Advanced Cervical Carcinoma
• Adverse Drug Event
• Anti-pd-1 Antibody
• Carcinoma
• Carcinoma, Neuroendocrine
• Cervical Neuroendocrine Carcinoma
• Chemotherapy
• Drug-Related Side Effects and Adverse Reactions
• Objective Response Rate
• Recurrent Cervical Carcinoma

Intervention

Drug:
• Drug therapy
6 courses of platinum/etoposide/bevacizumab/camrelizumab and a total period of 12 months bevacizumab/camrelizumab

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate	proportion of partial or complete remission after intervention	1 years
Secondary	severe adverse events	grade 3/4 adverse events and mortality according to criteria of Common Terminology Criteria for Adverse Events (CTCAE) and iRECIST Guideline	1 year
Secondary	a composite changes of important laboratory testing	these changes include liver/kidney/myocardiac functions, insulin resistance, functions of adrenal gland	1 year