Tislelizumab Plus TP as Neoadjuvant Therapy for Local Advanced Cervical Carcinoma

NCT ID: NCT05013268

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-12-31

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).

Conditions

Cervical Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Tislelizumab, paclitaxel/docetaxel, cisplatin/carboplatin

Intervention Type: DRUG

• 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yan Shi

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yan Shi

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, , China

Countries

China

Central Contacts

Yan Shi

Role: CONTACT

sy_rjh@aliyun.com

13810561979

Facility Contacts

Chenfei Zhou

Role: primary

Other Identifiers

TiTanec

Identifier Type: -

Identifier Source: org_study_id