Tislelizumab Plus TP as Neoadjuvant Therapy for Local Advanced Cervical Carcinoma

Cervical Squamous Cell Carcinoma Clinical Trial

— TiTanec  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05013268
• Other study ID #: TiTanec
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 2021
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: Ruijin Hospital
• Contact: Yan Shi
• Phone: 13810561979
• Email: sy_rjh[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

This phase I study is being conducted to establish efficacy and safety of Tislelizumab plus TP regimen (taxane combined with platinum) as neoadjuvant therapy for patients diagnosed as local advanced cervical carcinoma (FIGO staging IB2-IIB).

All enrolled patients will receive same intervention. Treatment naïve patients who are diagnosed as local advanced cervical squamous cell carcinoma will receive Tislelizumab plus TP regimen before surgery for 3 cycles. After treatment, radiographic evaluation will be performed to assess clinical efficacy. Patients who have objective response will undergo radical surgery. Patients who are disease stable or progression will undergo radical chemoradiotherapy. The primary endpoint is major pathological response rate (MPR).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Carcinoma
• Cervical Squamous Cell Carcinoma

Intervention

Drug:
• Tislelizumab, paclitaxel/docetaxel, cisplatin/carboplatin
Drug: Tislelizumab 200mg, d1, ivgtt, every 3 weeks, for 3 cycles Drug: Paclitaxel; docetaxel Dose: 175mg/m2 d1; 75mg/m2 d1, every 3 weeks, for 3 cycles Other Name: none Drug: Cisplatin; Carboplatin Dose: 75mg/m2 d1; AUC=5, d1, every 3 weeks, for 3 cycles Other Name: none

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai JiaoTong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

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