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Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas

NCT ID: NCT04635956

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2021-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Chemotherapy Anti-pd-1 Antibody Cervical Neuroendocrine Carcinoma Adverse Drug Event Recurrent Cervical Carcinoma Advanced Cervical Carcinoma Objective Response Rate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Intervention of platinum/etoposide/bevacizumab/camrelizumab
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

Patients will accept therapy consisting of platinum/etoposide/bevacizumab/camrelizumab

Group Type EXPERIMENTAL

Drug therapy

Intervention Type DRUG

6 courses of platinum/etoposide/bevacizumab/camrelizumab and a total period of 12 months bevacizumab/camrelizumab

Interventions

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Drug therapy

6 courses of platinum/etoposide/bevacizumab/camrelizumab and a total period of 12 months bevacizumab/camrelizumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lei Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Lei Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Li, M.D.

Role: CONTACT

Phone: +86-139-1198-8831

Email: [email protected]

Ming Wu, M.D.

Role: CONTACT

Phone: +86-138-0122-4549

Email: [email protected]

Facility Contacts

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Lei Li, MD

Role: primary

Other Identifiers

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CNET-PD1

Identifier Type: -

Identifier Source: org_study_id