A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary

NCT06279104 | Recruiting

• 1 other identifier: 2023-TJ-OCCC
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the treatment effectiveness of physician's choice of chemotherapy and the immune checkpoint inhibitor (ICI)-based therapy in patients with relapsed/refractory ovarian clear cell carcinoma (OCCC), and compare the treatment response with the phase II, single-arm clinical trial INOVA to investigate the efficacy of combinational therapy of sintilimab plus bevacizumab. The main questions it aims to answer are:

• What is the efficacy of physician's choice of chemotherapy in relapsed/refractory OCCC patients in the real world?
• Is ICI-based therapy more effective than physician's choice of chemotherapy in real-world for relapsed/refractory OCCC patients?
• Dose the combinational regimens of sintilimab plus bevacizumab in Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma (INOVA) trial more effective than physician's choice of chemotherapy? Participants will be respectively retrieved and extracted de-identified, longitudinal electronic health records (EHR)-derived data.

Conditions

Ovarian Clear Cell Carcinoma

Keywords

Ovarian clear cell carcinoma; real world study; immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (1)

• tumor response rate

  The tumor responses to treatment were evaluated by an independent central investigator according to RECIST version 1.1

  through study completion, an average of 1 year

Secondary Outcomes (4)

• progression-free survival (PFS)

  through study completion, an average of 1 year

• time to response (TTR)

  through study completion, an average of 3 months

• duration of response (DOR)

  through study completion, an average of 1 year

• disease control rate (DCR)

  through study completion, an average of 1 year

Study Arms (2)

real-world study (RWS)-Chemotherapy

Drug: physician's choice of chemotherapy

RWS-ICI

Drug: immune checkpoint inhibitor based therapy

Interventions

physician's choice of chemotherapy DRUG

physician's choice of chemotherapy for relapsed/refractory ovarian clear cell carcinoma

real-world study (RWS)-Chemotherapy

immune checkpoint inhibitor based therapy DRUG

immune checkpoint inhibitor based therapy for relapsed/refractory ovarian clear cell carcinoma

RWS-ICI

Eligibility Criteria

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

Study Population

Patients with relapsed/persistent OCCC were extracted de-identified, longitudinal electronic health records (EHR)-derived data from 12 tertiary hospitals in China since October 2008. Consecutive patients were enrolled with no restriction on treatment regimens.

You may qualify if:

• Female patients with age ≥ 18 years old and ≤ 75 years old.
• There must be a histological diagnosis of ovarian clear cell carcinoma.
• Patients with recurrent or persistent ovarian clear cell carcinoma must have at least one-line pretreated platinum-containing chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
• Expected survival time ≥ 12 weeks.

You may not qualify if:

• Histological evidence of non-ovarian clear cell carcinoma.

Sponsors & Collaborators

• Tongji Hospital: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Henan Cancer Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Hubei Cancer Hospital: collaborator
• Anhui Provincial Cancer Hospital: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Hunan Province Tumor Hospital: collaborator
• First Affiliated Hospital of Suzhou Medical College: collaborator
• Shandong Tumor Hospital: collaborator
• Chongqing University Cancer Hospital: collaborator
• First Affiliated Hospital of Zhongshan Medical University: collaborator
• Peking University Shenzhen Hospital: collaborator

Study Sites (1)

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Central Study Contacts

Qinglei Gao, PhD

CONTACT

+86 13871127473; qingleigao@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 26, 2024
• Study Start: March 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)