TQB2450 Plus Progestin for Fertility-sparing Treatment in MMRd EC

NCT06914297 | Recruiting Phase 2

• 1 other identifier: FST-dMMR-ICIs
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Based on the above situation, the investigators propose the following scientific hypothesis: In young patients with early MMRd type EC, the use of immune checkpoint inhibitors combined with progesterone for fertility retention therapy can improve the therapeutic efficacy, reduce recurrence, and improve tumor prognosis. Based on the above assumptions, this project intends to conduct a prospective exploratory clinical study in EC patients limited to the endometrial layer or superficial myometrium (FIGO 2023 IA1-IA2 stage). The subjects were treated with TQB2450 periodic intravenous drip + high-potency progesterone daily oral therapy. During the treatment period, hysteroscopy was performed every 12 weeks to evaluate the therapeutic efficacy. The primary endpoint was the 12-week CR rate; the secondary endpoints included the 24-week CR rate, the 36-week CR rate, the median CR time, the 1-year relapse rate, the 2-year relapse rate, the median relapse time, the pregnancy rate, the live birth rate, and drug-related adverse reactions. The exploratory indicators were the response of different MMRd tumors to immune checkpoint inhibitors and their possible mechanisms. The development of this study will provide a clinical basis for improving the fertility-preserving treatment regimen of MMRd EC.

Conditions

Endometrial Cancer

Keywords

endometrial cancer; Immune checkpoint inhibitor; fertility-sparing treatment; dMMR

Outcome Measures

Primary Outcomes (1)

• 3-month CR Rate

  Complete response rate at 12-16 weeks of treatment

  12-16 weeks

Secondary Outcomes (9)

• 6-month CR Rate

  24-28 weeks

• 9-month CR Rate

  36-40 weeks

• median complete response duration

  through study completion, an average of 2 years

• 1-year recurrence rate

  1 year after achieving CR

• 2-year recurrence rate

  2 years after achieving CR

Study Arms (1)

ICI plus P

EXPERIMENTAL

Initial hysteroscopic lesion resection and endometrial pathological evaluation were performed in patients who met the nanoparticle criteria, and drug therapy was initiated within one week: TQB2450 (1200 mg q3w ivgtt) + meprogesterone acetate (MA, 160 mg qdpo)/medroxyprogesterone acetate (MPA, 500 mg qdpo). Comprehensive/individualized hysteroscopic evaluation was performed at 12 weeks of treatment. According to the endometrial pathological results, radical surgery was recommended if the disease progressed (PD); if complete response/partial response (PR)/stable disease (SD) was achieved, the above regimen was continued with TQB2450 + MA/MPA. After 12 weeks of treatment, hysteroscopic comprehensive/individualized evaluation was performed again. According to the endometrial pathological results, if PR/SD/PD, radical surgical treatment was recommended. After treatment reached CR, the above regimen was continued to TQB2450 + MA/MPA consolidation treatment for 12 weeks.

Drug: TQB2450 injection + oral progestin

Interventions

TQB2450 injection + oral progestin DRUG

TQB2450 (1200 mg q3w ivgtt) + megestrol acetate (MA, 160 mg qd po)/megestrol acetate (MPA, 500 mg qd po)

ICI plus P

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age range from 18 to 45 years.
• Pathological diagnosis of endometrioid carcinoma by biopsy, diagnostic curettage or hysteroscopy, non-invasive (G1-2); clinical diagnosis by G1-2); clinical diagnosis confirmed by at least two associate senior physicians;
• Run possible, unknown EC;
• Intense MRI, enhanced MMRI, enhanced MRI/CT, and pulmonary CT, or PET/CT assessments indicated that the lesions were limited to the endometrial layer or superficial myometrium, and there was no clear deep myometrium, cervix, or extrauterine involvement.
• , WHFIGO 2023 IA1-IA2;
• EC molecular typing, resulting in MMRd type (molecular typing is based on the World Health Organization (WHO) classification criteria for female genital tumors (5th edition) );
• Those who require or insist on preserving reproductive function, or those who insist on preserving the uterus despite having no fertility requirements.
• informed

You may not qualify if:

• and can be followed up regularly in this hospital.
• Endometrioid carcinoma FIGO grade G3, type II EC (including serous carcinoma, clear cell carcinoma, carcinosarcoma, undifferentiated carcinoma, dedifferentiated carcinoma, neuroendocrine carcinoma, etc.), or other non-epithelial uterine malignancies (adenosarcoma, stromal sarcoma, etc.);
• Imaging evaluation indicates deep myometrial involvement, cervical involvement, or the possibility of extrauterine metastases.
• History of important organ transplantation;
• Uncontrolled diseases or active infections;
• Concomitant with severe acute diseases such as stroke, myocardial infarction, etc.
• Other malignant tumors of the reproductive system (except in patients with Lynch syndrome who also have ovarian cancer).
• Those who require hysterectomy or other methods of treatment other than conservative medication.
• Pregnant persons;
• Those who have received conservative treatment (or medication maintenance treatment) with high-potency progesterone or oral contraceptives for more than 1 month due to endometrial hyperplasia in the past three months;
• Smoking history, those who smoke more than 15 cigarettes per day;
• Those who are contraindicated in the use of immunosuppressants or progesterone.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Tenth People's Hospital of Tongji University

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Progestins

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)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Yu Xue, M.D

  Obstetrics & Gynecology Hospital of Fudan University

  STUDY DIRECTOR

Central Study Contacts

Xiaojun Chen, Ph.D, M.D

CONTACT

862133189900; cxjlhjj@163.com

Yu Xue, M.D

CONTACT

862163455050; xueyu_shuang@163.com

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: Vice President, Tenth People's Hospital of Tongji University, Shanghai, China

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 6, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)