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Cervical CancerPhase 2NCT04973904

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

A Phase 2 study testing Toripalimab, Paclitaxel and Cisplatin in people with Cervical Cancer, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cervical Cancer
What is being tested?
Toripalimab, Paclitaxel and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
1 Aug 2021to 1 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Controlled hepatitis B or hepatitis C subjects are eligible to participate in the study as long as they meet the following criteria: The HBV viral load must be less than 2,000 IU/mL (< 10000 copies/ml). Subjects have received anti-HBV therapy for 2 weeks before starting the study treatment and should maintain the same treatment throughout the study treatment period. Subjects with positive HCV RNA should receive anti-HCV therapy and liver function ≤ CTCAE Grade 1.
  • Subjects has not received corticosteroids or other immunosuppressive medications within 14 days prior to the study treatment.
  • Female subjects must not be pregnant, not breastfeeding, and at least one of the following conditions can be included in the study: women who do not have fertility or who agree to be at least 60 days after the treatment and the last study drug administration Fertility women who take contraceptive measures as required by the programme.

Who cannot join

  • 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
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  • 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
  • A history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months
  • Previous use of any anti-PD-1, anti-PD-L1 / L2 antibody, anti-CTLA-4 antibody and other immunotherapy and VEGF/VEGFR inhibitors (including bevacizumab)
  • Known hypersensitivity or allergy to paclitaxel, cisplatin, carboplatin, bevacizumab, Toripalimab or any of their excipients.
  • Another malignant tumor is known and is currently undergoing progress or has been actively treated in the past 3 years. Note: Subjects who have received skin basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ (eg, breast cancer, bladder cancer in situ) that may be curable may be treated.
  • Major surgery was performed within 3 weeks before enrollment or had not completely recovered from the previous surgery (the definition of major surgery refers to the level 3 and level 4 surgery in the administrative measures for clinical application of medical technology implemented on May 1, 2009)
  • Known mental illness or substance abuse conditions can impede the ability of the subject to meet research requirements
  • Poor compliance
  • Active pulmonary tuberculosis (TB), who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within one year before the first dose of treatment
  • A history of positive HIV
  • Patients with acute or chronic hepatitis B or hepatitis C infection, HBV DNA > 2000 IU / ml or 104 copies / ml; HCV RNA > 103 copies / ml; Hepatitis B surface antigen (HbsAg) and anti HCV antibody double positive.
  • Active autoimmune diseases, or have a history of autoimmune diseases or syndrome requiring systemic steroid / immunosuppressant use, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc
  • Administration of a live, attenuated vaccine within 28 days before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study
  • Currently participating in other clinical trials
  • Serious and uncontrollable comorbidities that may affect the compliance of the protocol or interfere with the results, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes, cardiovascular diseases (grade III or IV heart failure defined by the New York Heart Association classification), cardiac conduction block > secondary degree, myocardial infarction in the past 6 months, Unstable arrhythmia or unstable angina pectoris, cerebral infarction within 3 months, etc.) or pulmonary diseases (history of interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm)
  • Pregnant or lactating women
  • A history of allogeneic stem cell transplantation or organ transplantation
  • Patients who were not suitable for this study due to other reasons

Trial locations and contacts

1 site in 1 country.

Yang Xiang contact

010-69156068

XiangY@pumch.cn

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: A Single-Arm, Multicenter, Phase II Study to Investigate Efficacy and Safety of Toripalimab Combined With Chemotherapy and Bevacizumab as First-Line Treatment in Patients With Recurrent, Refractory and Metastatic Cervical Cancer

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

Read the detailed description

The objective of this study is to evaluate the efficacy and safety of therapy with toripalimab andchemotherapy (paclitaxel and cisplatin) and Bevacizumab as first-line treatment in patients with recurrent, refractory and metastatic cervical cancer

Conditions
Cervical Cancer
Keywords
Toripalimab
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04973904
Study groupRoleWhat they receive
PD-1+Paclitaxel+Cisplatin+BevacizumabExperimentalToripalimab 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)
Receives: Drug: Toripalimab; Drug: Paclitaxel; Drug: Cisplatin; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Secondary outcomes (3)

  1. Disease control rate

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

    Measured: 1 year

  2. progression free survival

    Time from cycle 1, day 1 of treatment to disease progression or death due to any cause

    Measured: 3 years

  3. Overall survival

    Time from cycle 1, day 1 of treatment until death due to any cause

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2021
  2. Study start1 Aug 2021 (estimated)
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04973904
Sponsor's protocol ID
JS001-ISS-CO214
Status last verified
Jul 2021
First submitted
8 Jul 2021
Last updated
22 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39482930

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab, Paclitaxel and Cisplatin in people with Cervical Cancer, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yang Xiang (010-69156068, XiangY@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04973904, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.

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Clinical Trial NCT04973904 | AzTrials