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NCT Number: NCT06279104

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

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.

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Key information

Conditions

Ovarian Clear Cell Carcinoma

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Qinglei Gao, PhD, MD

CONTACT

[email protected]

+86-13871127473

Qinglei Gao, PhD, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

1.Histological evidence of non-ovarian clear cell carcinoma.

Treatment and study plan

physician's choice of chemotherapy

Drug

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

immune checkpoint inhibitor based therapy

Drug

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

Primary outcomes

  1. tumor response rate

    Time frame: through study completion, an average of 1 year

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

Secondary outcomes

  1. progression-free survival (PFS)

    Time frame: through study completion, an average of 1 year

    the time from therapy initiation to the first documented progression or death from any cause, whichever occurred first

  2. time to response (TTR)

    Time frame: through study completion, an average of 3 months

    the time from therapy initiation to the first documented complete response or partial response

  3. duration of response (DOR)

    Time frame: through study completion, an average of 1 year

    the time from the first documented response to disease progression or death, whichever occurs first

  4. disease control rate (DCR)

    Time frame: through study completion, an average of 1 year

    the proportion of patients with complete response, partial response, and stable disease

Study contacts

Contact information is provided by the study sponsor or research team.

Qinglei Gao, PhD

CONTACT

[email protected]

+86 13871127473

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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