Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas

• Sponsor: Lei Li (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04635956
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy; Anti-pd-1 Antibody; Cervical Neuroendocrine Carcinoma; Adverse Drug Event; Recurrent Cervical Carcinoma; Advanced Cervical Carcinoma; Objective Response Rate	Drug: Drug therapy	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Intervention of platinum/etoposide/bevacizumab/camrelizumabIntervention of platinum/etoposide/bevacizumab/camrelizumab
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 15, 2020
• Anticipated Primary Completion Date: Nov 15, 2021
• Anticipated Study Completion Date: Nov 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group Patients will accept therapy consisting of platinum/etoposide/bevacizumab/camrelizumab	Drug: Drug therapy; 6 courses of platinum/etoposide/bevacizumab/camrelizumab and a total period of 12 months bevacizumab/camrelizumab

Outcome Measures

Primary Outcome Measures

1. objective response rate [1 years]

   proportion of partial or complete remission after intervention

Secondary Outcome Measures

1. severe adverse events [1 year]

   grade 3/4 adverse events and mortality according to criteria of Common Terminology Criteria for Adverse Events (CTCAE) and iRECIST Guideline

2. a composite changes of important laboratory testing [1 year]

   these changes include liver/kidney/myocardiac functions, insulin resistance, functions of adrenal gland

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lei Li	Beijing	Beijing	China	100730

Sponsors and Collaborators

• Lei Li

Investigators

• Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT04635956
• Other Study ID Numbers: CNET-PD1
• First Posted: Nov 19, 2020
• Last Update Posted: Nov 19, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Neuroendocrine; Recurrence; Drug-Related Side Effects and Adverse Reactions

Study Results

No Results Posted as of Nov 19, 2020