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Tislelizumab Combined With Chemotherapy in the Treatment of Bone Metastases of Unknown Primary

NCT05241132 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-02-15

No results posted yet for this study

Summary

Through scientific and rigorous design, implementation, follow-up and statistics, the sponsor aims to explore the clinical efficacy and safety of Tislelizumab combined with chemotherapy (platinum + paclitaxel) in the treatment of patients with bone metastases cancer with unknown primary, and provide a better treatment plan for these patients.

1. Primary outcome: Objective response rate (ORR)
2. Secondary outcomes: disease control rate (DCR), duration of remission (DOR), progression-free disease (PFS), overall survival (OS), median PFS, median OS, stratification based on clinical features and PD-L1 expression, adverse reactions (AEs), and quality of life.

Conditions

  • Cancer of Unknown Primary
  • Bone Cancer Metastatic
  • Tislelizumab
  • Gene Mutation-Related Cancer
  • Immune Evasion, Tumor
  • Chemotherapy Effect

Interventions

DRUG

Tislelizumab plus chemotherapy

1. Cisplatin: 100mg/m2, injected intravenously every 3 weeks, 8 cycles (period 21 days) 2. Paclitaxel (albumin-bound) : paclitaxel, 175mg/m2, given intravenously every 3 weeks for 8 cycles (period 21 days). 3. Tislelizumab: 200mg, given intravenously every 3 weeks until disease progression or unacceptable toxicity or death or subject withdrawal of informed consent.

Sponsors & Collaborators

  • Wei Xu

    lead OTHER

Principal Investigators

  • Jianru Xiao, Profession · Chang Zheng Hospital

  • Wei Xu, Profession · Chang Zheng Hospital

  • Bo Li, Profession · Chang Zheng Hospital

  • Hao Jiang, Doctor · Chang Zheng Hospital

  • Pengru Wang, Doctor · Chang Zheng Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-12
Primary Completion
2023-06-30
Completion
2024-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05241132 on ClinicalTrials.gov