Toripalimab Combined With Chemotherapy and Bevacizumab as First-Line Treatment in Patients With Advanced Cervical Cancer

NCT04973904 | Unknown Phase 2

• 1 other identifier: JS001-ISS-CO214
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, multicenter, phase II study to investigate efficacy and safety of Toripalimab combined with chemotherapy (paclitaxel and cisplatin) and Bevacizumab as first-line treatment in patients with recurrent, refractory and metastatic cervical cancer

Conditions

Cervical Cancer

Keywords

Toripalimab

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1

  1 year

Secondary Outcomes (3)

• Disease control rate

  1 year

• progression free survival

  3 years

• Overall survival

  3 years

Study Arms (1)

PD-1+Paclitaxel+Cisplatin+Bevacizumab

EXPERIMENTAL

Toripalimab 240mg intravenously(IV) every 3 weeks (Q3W) Paclitaxel 175mg/m2 IV every 3 weeks (Q3W) Cisplatin 50mg/m2 (Q3W) Bevacizumab 7.5mg/kg IV every 3 weeks (Q3W)

Drug: Toripalimab; Drug: Paclitaxel; Drug: Cisplatin; Drug: Bevacizumab

Interventions

Toripalimab DRUG

IV infusion

PD-1+Paclitaxel+Cisplatin+Bevacizumab

Paclitaxel DRUG

IV infusion

PD-1+Paclitaxel+Cisplatin+Bevacizumab

Cisplatin DRUG

IV infusion

PD-1+Paclitaxel+Cisplatin+Bevacizumab

Bevacizumab DRUG

IV infusion

PD-1+Paclitaxel+Cisplatin+Bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Cervical squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma diagnosed by histopathology
• FIGO stage IVB according to 2018 FIGO staging classification; Any FIGO stage with persistent or progressed lesions after treatment; Any FIGO stage with recurrent lesions and recurrent-free interval \> 6 month
• Subjects has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation). Subject who previously treated with cisplatin-based CCRT is allowed
• Has measurable disease per RECIST 1.1
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Written and signed informed consent.
• Patients must have adequate function as defined:
• ANC≥1.5\*10\^9/L; PLT≥100\*10\^9/L, Hb≥90 g/L, WBC≥3.5\*10\^9/L
• Total Bilirubin (TBIL)≤1.5\*Upper Limit of Normal(UNL)
• Alanine Transaminase (ALT)and Aspartate Aminotransferase(AST)≤2.5\*ULN.For liver metastasis patients, ALT and AST≤5\*ULN, Alkaline phosphatase (ALP) ≤ 3 x UNL. For liver metastasis patients, Alkaline phosphatase (ALP) ≤ 5 x UNL
• Cr≤ ULN, or creatinine clearance rate ≥60 mL/min,
• Proteinuria ≤1+，if proteinuria≥ 1+ and 24 hours total urine protein ≤ 1.0 g
• Patients who did not receive anticoagulant therapy: INR ≤ 1.5 × ULN. If the patient receives prophylactic anticoagulant therapy, the INR ≤ 2 × ULN within 14 days before the start of the study treatment and the activated partial thromboplastin time is within the normal range, acceptable for enrollment
• Has not a history of autoimmune diseases

You may not qualify if:

• Prior systemic treatment for recurrent, secondarily progressive or initially metastatic disease
• Indications for potentially curative treatment (surgery or radiation therapy)
• Has received prior radiotherapy within 2 weeks before enrollment,or has not recovered from the effects of radiotherapy.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with known brain metastases may participate provided that the brain metastases have been previously treated with radiotherapy or surgery only and are radiographically stable
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently); Patients with stable symptoms for at least two weeks after drainage could be enrolled
• Patients with cirrhosis of any cause
• Major surgery, open biopsy or major trauma were performed within 28 days before the first dose of treatment
• Gastrointestinal or other active bleeding, gastrointestinal perforation
• History of organ fistula (such as gallbladder fistula, tracheal fistula, pancreatic fistula, etc.)
• Coagulation disorder or thromboembolic disease without standard anticoagulant therapy
• uncontrolled hypertension, hypertensive crisis, hypertensive encephalopathy
• Patients with severe wounds that cannot be healed, ulcers or fractures
• Grade ≥ 3 venous thromboembolic events (VTE)
• History of arterial thromboembolism
• Acute intestinal obstruction in the last 6 months

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• Li C, Liu S, He Y, Yao H, Yuan Z, Yang J, Cao D, Cheng N, Yang J, Peng P, Xiang Y. Toripalimab combined with bevacizumab plus chemotherapy as first-line treatment for refractory recurrent or metastatic cervical cancer: a single-arm, open-label, phase II study (JS001-ISS-CO214). J Gynecol Oncol. 2025 May;36(3):e44. doi: 10.3802/jgo.2025.36.e44. Epub 2024 Oct 25.

  PMID: 39482930 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

toripalimab; Paclitaxel; Cisplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yang Xiang

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Xiang

CONTACT

010-69156068; XiangY@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 22, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

CN (1)