CNCMT：a Multi-center, Prospective, Single-arm Study

NCT06714084 | Enrolling By Invitation DMC

• 2 other identifiers: CNCMTChiCTR2400088236
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of Cadonilimab in neoadjuvant chemotherapy and maintenance therapy for high-risk advanced cervical cancer receiving concurrent chemoradiotherapy

Conditions

Locally Advanced Cervical Cancer; PD1; CTLA4

Keywords

cervical cancer; Cadonilimab; maintenance therapy

Outcome Measures

Primary Outcomes (2)

• Progression-free survival rate at 12 months

  Progression-free survival rate at 12 months after receiving treatment

  up to 12 months

• Objective response rate(ORR) of neoadjuvant therapy

  Proportion of patients with complete response（CR） and partial response(PR) of the neoadjuvant therapy

  About 2 months

Secondary Outcomes (2)

• mPFS

  through study completion, an average of 24 months

• mOS

  through study completion, an average of 6 years

Study Arms (1)

Experimental Group

EXPERIMENTAL

Cadonilimab in neoadjuvant chemotherapy and maintenance therapy for newly diagnosed advanced cervical cancer

Drug: Neoadjuvant Chemotherapy (NACT); Drug: maintenance therapy

Interventions

Neoadjuvant Chemotherapy (NACT) DRUG

Two cycles of carbonilumab plus TP regimen neoadjuvant chemotherapy will be implemented to patients with advanced cervical cancer

Experimental Group

maintenance therapy DRUG

one years of maintenance therapy with carbonilumab alone will be implemented to patients with advanced cervical cancer receiving standard concurrent chemoradiotherapy

Experimental Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Hubei Cancer Hospital: lead
• Yichang Central People's Hospital: collaborator
• Akeso Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Neoadjuvant Therapy; Maintenance

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Health Care Facilities Workforce and Services

Study Officials

• HUANG YI, Master's degree

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Archiater

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 3, 2024
• Study Start: October 8, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From December 2024 to December 2030
• Access Criteria: Healthcare workers, accessed at the following web site:https://www.chictr.org.cn/showproj.html?proj=233028

Locations

CN (1)