Tislelizumab in Combination With Chemotherapy as a Neoadjuvant Treatment for Advanced Endometrial Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorZhongnan Hospital

About this trial

The goal of this clinical trial is to evaluate the efficacy and safety of tislelizumab in combination with chemotherapy as a neoadjuvant treatment for advanced endometrial cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary participation and signed informed consent form;

Age ≥18 years;

Eastern Cooperative Oncology Group performance status 0-1;

The International Federation of Gynecology and Obstetrics (FIGO 2023) stage III-IVb of endometrial cancer;

Disqualifiers

Received PD-1 target therapy other than tislelizumab or other antibody or drug therapy that specifically targets T-cell costimulation or checkpoint channels within 6 months before enrollment;

Has human immunodeficiency virus infection, active viral hepatitis, and active tuberculosis infection;

Active leptomeningeal disease or uncontrolled, untreated brain metastases resulting in elevated intracranial pressure;

Major surgical procedures had been performed within 4 weeks before consent was obtained;

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Drug

    Tislelizumab 200mg D1 ,Q3W

  • Paclitaxel

    Drug

    Paclitaxel(175 mg/m2 ) D1,Q3W

  • Carboplatin

    Drug

    Carboplatin(AUC=5) D1,Q3W

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Tislelizumab+Carboplatin+PaclitaxelExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

R0 resection rate (R0 %)

R0 resection rate is defined as the percentage of eligible patients that underwent a microscopically complete (or R0) resection. The resection is considered R0 if the inked margin is further than 1 mm distinct from any tumour cells.

Time frame
Up to approximately 24 months

Secondary outcomes

1

Pathological complete response rate (pCR%)

pCR is defined as the absence of invasive cells at microscopic examination of the primary tumor and lymph nodes at surgery. Any remaining in-situ lesions are permissible.

Time frame
Up to approximately 24 months
2

Objective Response Rate (ORR%)

ORR (either confirmed complete response \[CR\] or partial response \[PR\]) based on RECIST 1.1 will be determined in participants who have measurable disease at study entry.

Time frame
Up to approximately 24 months
3

Progression free survival (PFS)

PFS is defined as the time from the date of first dose to the earlier date of assessment of progression or death by any cause.

Time frame
Up to approximately 24 months
4

Recurrence free survival (RFS)

RFS is defined as the time from metastasectomy until progression by RECIST 1.1 or death from any cause.

Time frame
Up to approximately 24 months

Other outcomes

Sponsors and contacts

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