Tislelizumab Plus TP as Neoadjuvant Therapy for Local Advanced Cervical Carcinoma

NCT05013268 | Unknown Phase 1

• 1 other identifier: TiTanec
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Cervical Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pathological Complete Response (pCR) Rate

  Up to approximately 8 weeks following completion of neoadjuvant treatment

• Objective response rate (ORR)

  Up to 30 days after last completion of neoadjuvant treatment

• Relapse free survival (RFS)

  Up to approximately 36 months

• Disease free survival (DFS)

  Up to approximately 36 months

• Adverse Events

  Up to approximately 12 months

Other Outcomes (1)

• Biomarkers analysis

  Up to approximately 12 months

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: Tislelizumab, paclitaxel/docetaxel, cisplatin/carboplatin

Interventions

Tislelizumab, paclitaxel/docetaxel, cisplatin/carboplatin 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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. Other unsuitable conditions determined by investigators.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, China

Location

MeSH Terms

Interventions

tislelizumab; Paclitaxel; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Yan Shi

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Shi

CONTACT

13810561979; sy_rjh@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 19, 2021
• Study Start: September 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)