Cervical Squamous Cell Carcinoma Clinical Trial
— TiTanecOfficial title:
The Efficacy and Safety of Tislelizumab Combined With Taxanes and Platinum as Neoadjuvant Therapy for Patients With Local Advanced Cervical Carcinoma, an Open Lable,Single-center, Exploratory Clinical Trial
Verified date | August 2021 |
Source | Ruijin Hospital |
Contact | Yan Shi |
Phone | 13810561979 |
sy_rjh[@]aliyun.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical trail is to investigate the efficacy and safety of PD-1 antibody Tislelizumab plus TP regimen (taxane combined with platinum) as neoadjuvant therapy for patients diagnosed as local advanced cervical carcinoma (FIGO staging IB2-IIB).
Status | Not yet recruiting |
Enrollment | 15 |
Est. completion date | December 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Histologically confirmed cervical squamous cell carcinoma. 2. Clinical staging FIGO IB2-IIB, treatment naive. 3. Female patients aged=18 years. 4. ECOG performance status 0 or 1, expected lifetime=3 months. 5. Adequate organ function: Absolute neutrophil count (ANC) =1.5x109/L, White blood count =3.5x109/L, Platelets =75x109/L, Hemoglobin (Hb) =90g/L, ALT/AST =2.5x ULN, Serum bilirubin =1.5x ULN, Serum creatinine =1.5x ULN. 6. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA<500IU/ml (or 2500 copies/ml). 7. Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment. 8. Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form. Exclusion Criteria: 1. Pregnancy or children bearing potential. 2. brain or meningeal metastasis. 3. With second primary malignant diseases. 4. With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone). 5. With uncontrollable complications 6. Inadequate organ function 7. Known hypersensitivity reaction to any of the study drugs or components. 9. Other unsuitable conditions determined by investigators. |
Country | Name | City | State |
---|---|---|---|
China | Ruijin Hospital, Shanghai JiaoTong University School of Medicine | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Biomarkers analysis | The association between biomarkers expression (eg. PD-L1 CPS) in primary tumor and efficacy. | Up to approximately 12 months | |
Primary | Major pathological response (MPR) rate | Major pathological response rate is defined as the percentage of participants having =10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. | Up to approximately 8 weeks following completion of neoadjuvant treatment | |
Secondary | Pathological Complete Response (pCR) Rate | rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy. | Up to approximately 8 weeks following completion of neoadjuvant treatment | |
Secondary | Objective response rate (ORR) | Objective Response Rate is defined as the percentage of patients with a documented complete response or partial response (CR + PR) based on RECIST v1.1. | Up to 30 days after last completion of neoadjuvant treatment | |
Secondary | Relapse free survival (RFS) | Relapse free survival is defined as the time from surgery to first local, regional, or distant tumor recurrence or metastasis, or deaths. | Up to approximately 36 months | |
Secondary | Disease free survival (DFS) | disease-free survival (DFS) is defined as surgery until documented disease recurrence or death from any cause in all patients (ITT population) who undergo surgery | Up to approximately 36 months | |
Secondary | Adverse Events | All patients who have received at least one dose of treatment will be included in the safety analysis. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Up to approximately 12 months | |
Secondary | Overall survival (OS) | Overall survival is defined as the time from signing ICF until death from any cause. | Up to approximately 60 months |
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