Clinical Efficacy Study of PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Advanced Endometrial Cancer

NCT06561308 | Recruiting Phase 2 DMC

• 1 other identifier: PRO2024393
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Exploring the therapeutic effect of neoadjuvant chemotherapy combined with PD-1 inhibitor camrelizumab on advanced stage III-IV endometrial cancer

Conditions

Endometrioid Endometrial Cancer

Keywords

Neoadjuvant chemotherapy; PD-1 inhibitor (Camrelizumab)

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response

  Proportion of patients with no tumor cells on postoperative pathology and negative lymph node metastasis

  At the end of the patient's treatment, up to 1 years.

Secondary Outcomes (5)

• Surgical complication rate

  During and after the surgery, up to 2 years.

• Adverse Event

  during the treatment, up to 5 years.

• Remission rate (%) as assessed by RECIST 1.1 criteria

  At the end of the patient's treatment, up to 1 years.

• Event-free survival (EFS)

  Until the end of the 3-year follow-up period, up to 5 years.

• Overall survival (OS)

  Until the end of the 3-year follow-up period, up to 5 years.

Study Arms (1)

Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma

EXPERIMENTAL

Patients with advanced endometrial cancer were enrolled for 2-3 cycles of neoadjuvant chemotherapy in combination with camrelizumab, with imaging to assess efficacy; intermittent subtractive surgery (transabdominal hysterectomy + bilateral adnexectomies + pelvic lymph node dissection + pelvic and abdominal tumors resections +/- para-abdominal aortic lymph node dissection) was performed in patients with complete remissions (CR)/partial remissions (PR), and continued with 3-4 cycles of neoadjuvant chemotherapy in combination with camrelizumab.

Drug: Camrelizumab; Drug: Carboplatin; Drug: Paclitaxel; Procedure: Surgery

Interventions

Camrelizumab DRUG

Camrelizumab is administered at 200mg, q3w，intravenous infusion

Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma

Carboplatin DRUG

AUC=4-6，q3w，intravenous infusion

Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma

Paclitaxel DRUG

175 mg/m2，q3w，intravenous infusion, administered over 30min.

Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma

Surgery PROCEDURE

Transabdominal hysterectomy + bilateral adnexectomy + pelvic lymph node dissection + pelvic-abdominal tumor resection +/- para-abdominal aortic lymph node dissection

Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma

Eligibility Criteria

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

You may qualify if:

• Endometrial cancer initially diagnosed as stage III non-operable resectable, stage IV (FIGO, 2009 criteria) after imaging evaluation
• Pathologically confirmed endometrial cancer that looks like endometrial carcinoma
• Patient age ≥18 years and ≤75 years old
• ECOG status score of 0-1
• tolerate surgery and radiotherapy
• Laboratory tests: WBC ≥3.5×109/L, NEU ≥1.5×109/L, PLT ≥80×109/L, serum ≥80×109/L, serum ≥80×109/L, serum ≥80×109/L, serum ≥80×109/L.
• ×109/L, serum bilirubin ≤1.5 times the high limit of normal value, transaminase ≤1.5 times the high limit of normal value, BUN ≤1.5 times the high limit of normal value.
• times of the high limit of normal value, BUN, Cr≤normal value;
• Able to follow up and good compliance;
• Able to sign the informed consent form, including compliance with the requirements and restrictions listed in the informed consent form and the program.

You may not qualify if:

• Subjects with an active, known, or suspected autoimmune disease, or a history of an autoimmune disease, except for: vitiligo, alopecia areata, Graves' disease, psoriasis, or eczema that has not required systemic therapy within the last 2 years, hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis), type 1 diabetes that requires only stable doses of insulin replacement therapy, asthma that subsides completely in childhood and does not require intervention in adulthood, or diseases that do not recur in the absence of external triggers;
• Prior treatment with immune checkpoint inhibitors, including, but not limited to, other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or any treatment directed against immune co-stimulators (e.g., antibodies directed against ICOS, CD40, CD137, GITR, OX40 targets, etc.) that target any mechanism of immune action against tumors;
• Known hypersensitivity to any component and/or any excipient of the trial regimen;
• Immunosuppressive drugs or systemic corticosteroids for immunosuppression (\>10 mg/day of prednisone or other equivalent) within 2 weeks prior to trial dosing; topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted;
• Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2) within 2 weeks prior to the trial;
• Active systemic infection requiring systemic treatment;
• Serious infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;
• Patients with untreated chronic hepatitis B, or HBV carriers with chronic hepatitis B virus (HBV) DNA greater than 1,000 IU/mL, or patients with active hepatitis C. Inactive HBsAg carriers, treated hepatitis B patients with stable disease (HBV DNA \< 1000 IU/mL), and cured hepatitis C patients will be eligible for enrollment. HCV antibody-positive subjects will be eligible for the study only if they have a negative HCV RNA test;
• Immunodeficiency or human immunodeficiency virus (HIV antibody positive);
• Subjects with active inflammatory bowel disease or a history of such disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea). Subjects who are unable to swallow or who have malabsorption syndrome, uncontrolled nausea, vomiting, diarrhea, or other gastrointestinal disorders that severely interfere with drug intake and absorption;
• Known interstitial lung disease that is symptomatic or may interfere with detection or treatment of immune-associated pneumonia;
• Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first trial dose, inactivated seasonal influenza virus vaccine is permitted;
• Patients who have received a prior allogeneic bone marrow transplant or solid organ transplant;
• History of primary malignant tumor within the last 5 years;
• Subjects who have undergone major surgery (e.g., open abdomen, open chest, organ resection, etc.) and severe trauma within 28 days prior to the first dose of implantable infusion devices are permitted;

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead
• Xiangya Hospital of Central South University: collaborator
• Tongji Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Anhui Provincial Cancer Hospital: collaborator
• Sichuan Cancer Hospital and Research Institute: collaborator
• Henan Provincial People's Hospital: collaborator
• Hunan Cancer Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Ningbo No. 1 Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

Women's hospital school of medicine zhejiang university

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; Carboplatin; Paclitaxel; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Hui Wang, PHD

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Li, PHD

CONTACT

0086-0571-87061501; li_yang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Carboplatin AUC=4-6 q3w , paclitaxel 175 mg/m2 q3w and Camrelizumab iv.200mg q3w

Study Record Dates

• First Submitted: August 17, 2024
• First Posted: August 20, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2031
• Last Updated: December 1, 2025

Record last verified: 2025-08

Locations

CN (1)