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Tislelizumab Plus TP as Neoadjuvant Therapy for Local Advanced Cervical Carcinoma (TiTanec)

Primary Purpose

Cervical Squamous Cell Carcinoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Tislelizumab, paclitaxel/docetaxel, cisplatin/carboplatin

About this trial

This is an interventional treatment trial for Cervical Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed cervical squamous cell carcinoma.
Clinical staging FIGO IB2-IIB, treatment naive.
Female patients aged≥18 years.
ECOG performance status 0 or 1, expected lifetime≥3 months.
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.
HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA<500IU/ml (or 2500 copies/ml).
Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
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:

Pregnancy or children bearing potential.
brain or meningeal metastasis.
With second primary malignant diseases.
With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone).
With uncontrollable complications
Inadequate organ function
Known hypersensitivity reaction to any of the study drugs or components.

9. Other unsuitable conditions determined by investigators.

Sites / Locations

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tislelizumab plus TP regimen as neoadjuvant therapy for local advanced cervical carcinoma

Arm Description

Experimental: Tislelizumab, paclitaxel/docetaxel, cisplatin/carboplatin The subjects enrolled in this trial will receive tislelizumab 200mg ivgtt d1, paclitaxel (175mg/m2 ivgtt d1) or docetaxel (75mg/m2 ivgtt d1), cisplatin (75mg/m2 ivgtt d1) or carboplatin (AUC=5 ivgtt d1). The regimen will be repeated every 3 weeks for 3 cycles. Chemotherapy regimen will be selected by investigators. Subjects will be enrolled serially.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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

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

Overall survival (OS)

Overall survival is defined as the time from signing ICF until death from any cause.

Full Information

NCT ID

NCT05013268

First Posted

August 17, 2021

Last Updated

August 18, 2021

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05013268

Brief Title

Tislelizumab Plus TP as Neoadjuvant Therapy for Local Advanced Cervical Carcinoma

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 2021 (Anticipated)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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).

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Squamous Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tislelizumab plus TP regimen as neoadjuvant therapy for local advanced cervical carcinoma

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Tislelizumab, paclitaxel/docetaxel, cisplatin/carboplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Major pathological response (MPR) rate

Description

Time Frame

Up to approximately 8 weeks following completion of neoadjuvant treatment

Secondary Outcome Measure Information:

Title

Pathological Complete Response (pCR) Rate

Description

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.

Time Frame

Up to approximately 8 weeks following completion of neoadjuvant treatment

Title

Objective response rate (ORR)

Description

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.

Time Frame

Up to 30 days after last completion of neoadjuvant treatment

Title

Relapse free survival (RFS)

Description

Relapse free survival is defined as the time from surgery to first local, regional, or distant tumor recurrence or metastasis, or deaths.

Time Frame

Up to approximately 36 months

Title

Disease free survival (DFS)

Description

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

Time Frame

Up to approximately 36 months

Title

Adverse Events

Description

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

Time Frame

Up to approximately 12 months

Title

Overall survival (OS)

Description

Overall survival is defined as the time from signing ICF until death from any cause.

Time Frame

Up to approximately 60 months

Other Pre-specified Outcome Measures:

Title

Biomarkers analysis

Description

The association between biomarkers expression (eg. PD-L1 CPS) in primary tumor and efficacy.

Time Frame

Up to approximately 12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed cervical squamous cell carcinoma. Clinical staging FIGO IB2-IIB, treatment naive. Female patients aged≥18 years. ECOG performance status 0 or 1, expected lifetime≥3 months. 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. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA<500IU/ml (or 2500 copies/ml). Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment. 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: Pregnancy or children bearing potential. brain or meningeal metastasis. With second primary malignant diseases. With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone). With uncontrollable complications Inadequate organ function Known hypersensitivity reaction to any of the study drugs or components. 9. Other unsuitable conditions determined by investigators.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Shi

Phone

13810561979

sy_rjh@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yan Shi

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

City

Shanghai

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chenfei Zhou

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Tislelizumab Plus TP as Neoadjuvant Therapy for Local Advanced Cervical Carcinoma

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