Oral Topotecan With Toripalimab for Patients With Endometrial Cancer

NCT06548763 | Not Yet Recruiting Phase 2

• 1 other identifier: ECR-TT-2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the safety and efficacy of oral topotecan combined with toripalimab in treating advanced/recurrent endometrial cancer through a single-center, prospective, single-arm, phase II clinical trial. The goal is to explore the first-line treatment options for endometrial cancer patients in the era of immunotherapy, to improve the overall treatment level and prognosis of endometrial cancer.

Conditions

Endometrial Cancer

Keywords

Endometrial Cancer; Topotecan; Toripalimab

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression free survival

  Two years

Secondary Outcomes (2)

• OS

  Two years

• ORR

  Two years

Other Outcomes (1)

• Tumor markers

  Two years

Study Arms (1)

Topotecanwith Terriptylimab

EXPERIMENTAL

Oral administration of topotecan and intravenous infusion of trastuzumab until disease progression or toxicity intolerance occurs.

Drug: Topotecan; Drug: Toripalimab

Interventions

Topotecan DRUG

1.4mg/㎡, orally administered, d1-5

Topotecanwith Terriptylimab

Toripalimab DRUG

240mg, intravenous drip, d1, q3w

Topotecanwith Terriptylimab

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old, female;
• Patients with advanced/recurrent endometrial cancer diagnosed by histopathology and failed first-line treatment;
• Can provide 10 pathological white films for subsequent research;
• Physical fitness status score ECOG ≤ 2;
• Expected survival period ≥ 3 months;
• The subjects can understand the research process, voluntarily participate in this study, sign informed consent forms, have good compliance, and cooperate with follow-up.

You may not qualify if:

• Pregnant and lactating patients, women of childbearing age who refuse to take effective contraceptive measures during the study period; Individuals with peripheral nervous system disorders caused by diseases or those with a history of significant mental and central nervous system disorders;
• Serious or uncontrolled infections that may affect research treatment or evaluation of research results, including but not limited to active hepatitis virus infections, positive human immunodeficiency virus (HIV) antibodies, lung infections, etc;
• Individuals who are known to be allergic, highly sensitive, or intolerant to the active ingredients or other components of the investigational drug;
• Other malignant tumors have appeared within the past 5 years, except for cured cervical carcinoma in situ and non melanoma skin cancer;
• Patients who are currently participating or have participated in other clinical trials within the past month;
• The researchers determined that the patients were not suitable to participate in this study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan university shanghai cancer center, Deparment of gynecologic oncology

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Topotecan; toripalimab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Central Study Contacts

Hao Wen, MD

CONTACT

+86-021-64175590; wenhao@shca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gynecological Oncology

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: August 12, 2024
• Study Start: November 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)