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

Sponsor
Women's Hospital School Of Medicine Zhejiang University
Study ID
NCT06561308
Phase
PHASE2
Status
Recruiting
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Conditions

  • Endometrioid Endometrial Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Camrelizumab is administered at 200mg, q3w，intravenous infusion
  • Carboplatin — DRUG
    AUC=4-6，q3w，intravenous infusion
  • Paclitaxel — DRUG
    175 mg/m2，q3w，intravenous infusion, administered over 30min.
  • Surgery — PROCEDURE
    Transabdominal hysterectomy + bilateral adnexectomy + pelvic lymph node dissection + pelvic-abdominal tumor resection +/- para-abdominal aortic lymph node dissection

Study Details

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

Key Dates

Start date
Sep 1, 2025
Status verified
Aug 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2031

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma
    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.

Primary Outcome Measure

Pathologic complete response [ Time Frame: At the end of the patient's treatment, up to 1 years. ]

Central Contacts

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