- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04341883
Study of Anti-PD-1 Combined With Albumin-Bound Paclitaxel in Patients With Recurrent Cervical Cancer
May 26, 2022 updated by: Xin Huang, Sun Yat-sen University
A Open-label, Single-arm, Multicentre, Phase Ⅱ Study of Evaluate Efficacy and Safety of Anti-PD-1 Combined With Albumin-Bound Paclitaxel in Patients With Recurrent Cervical Cancer
This is an open-label, single-arm, phase II, multi-center clinical trial.
Subjects can only enter this study after they meet the inclusion and exclusion criteria.
All enrolled patients will receive the treatment with anti-PD-1 combined with albumin-bound paclitaxel, every 3 weeks, until progressive disease, initiation of new anti-tumour therapy, death, intolerable toxicity.
Albumin-bound paclitaxel may be used for up to 6 cycles and anti-PD-1 for up to 2 years.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Sun Yat-sen University Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Voluntarily participate and have signed the informed consent form (ICF);
- Patients histologically diagnosed with cervical cancer ;
- Patients with advanced cervical cancer who have experienced progressive disease or relapse after receiving standard treatment (first-line chemotherapy must be included) or who are intolerant to first-line chemotherapy.
- The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1;
- An Eastern Cooperative Oncology Group(ECOG) score of 0 or 1;
- Life expectancy ≥ 3 months;
- Adequate hepatic, renal, heart, and hematologic functions. Absolute Neutrophil Count(ANC) ≥ 1.5×109/L, Platelet (PLT) ≥ 70×109/L, Hemoglobin(HGB) ≥ 80 g/L, total bilirubin within 1.5×the upper limit of normal (ULN), and serum transaminase≤2.5×Upper Limit Of Normal(ULN), serum creatine ≤ 1.5 x Upper Limit Of Normal(ULN), creatinine clearance rate ≥50ml/min, International Normalized Ratio<1.5 x Upper Limit Of Normal(ULN), Urinary protein≤(+)and Thyroid stimulating hormone≤ 1.5 x Upper Limit Of Normal(ULN).
Exclusion Criteria:
- Pathology confirmed with sarcoma components (including malignant mixed mullerian tumors, endometrial leiomyosarcoma, and endometrial stromal sarcoma);
- Patients who have previously received albumin-bound paclitaxel or exposures to any anti-PD-1 antibody drugs;
- Exposures to any anti-tumor drugs within 4 weeks;
- Current or prior use of any immunosuppressive medication or systemic hormone therapy(which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid Prednisone>10mg/d)within 14 days before the first dose of anti-PD-1 antibody;
- Any primary malignancy within 5 years (except for fully treated in situ malignant such as breast cancer, bladder cancer, cervical carcinoma in situ, cutaneous basal cell carcinoma or squamous cell carcinoma);
- History of psychiatric drugs abuse and not be abstinent, or dysphrenia;
- Central nervous system diseases, including uncontrollable epilepsy and symptomatic brain metastases;
- Severe cardiovascular disease: unstable angina pectoris, myocardial infarction, grade III-IV cardiac insufficiency (NYHA standard), and peripheral vascular disease above 2 degrees within 6 months prior to enrollment;
- Severe arrhythmia requiring drug control, QT interval >470ms;
- Active infections such as HIV/AIDS or other serious infectious diseases;
- Any active autoimmune disease or history of autoimmune disease (including but not limit to autoimmune hepatitis, interstitial pneumonia, hepatitis, enteritis, nephritis, hyperthyroidism, pituitary inflammation, vasculitis, uveitis) . Patients need receiving systemic hormonal therapy and/or immunosuppressive therapy (eg asthma requiring bronchodilators);
- Receipt of live attenuated vaccination within 30 days prior to study entry;
- Other conditions regimented at investigators' discretion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: anti-PD-1
PD-1+albumin-bound paclitaxel
|
anti-PD-1: 200mg/3w+Albumin-bound paclitaxel: 260 mg/m2/3w.Albumin-bound paclitaxel may be used for up to 6 cycles, and anti-PD-1 for up to 2 years. Other Name: Programmed cell death 1 antibody |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate(ORR)
Time Frame: up to 2 years
|
Objective tumor response was defined as the proportion of patients whose tumor volume has been reduced to a predetermined value and can be maintained for more than 4 weeks, ie ORR=CR+PR.
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival(PFS)
Time Frame: up to 2 years
|
Progression-free survival was defined as the duration of time from study entry to time of progression, death, or the date of last contact, whichever occurs first.
|
up to 2 years
|
Overall Survival(OS)
Time Frame: up to 2 years
|
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
|
up to 2 years
|
Disease Control Rate(DCR)
Time Frame: up to 2 years
|
Disease control rate was defined as the proportion of subjects with complete response (CR) or partial response (PR) or disease stabilization (SD) in the analyzed population according to the RECIST 1.1 criteria.
|
up to 2 years
|
Duration of Response(DoR)
Time Frame: up to 2 years
|
Duration of response was defined as the time when the tumor is first evaluated as CR or PR to the first assessment for progressive disease(PD) or for any cause of death.
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 13, 2019
Primary Completion (ANTICIPATED)
June 1, 2022
Study Completion (ANTICIPATED)
December 1, 2023
Study Registration Dates
First Submitted
April 8, 2020
First Submitted That Met QC Criteria
April 9, 2020
First Posted (ACTUAL)
April 10, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 27, 2022
Last Update Submitted That Met QC Criteria
May 26, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Disease Attributes
- Uterine Cervical Neoplasms
- Recurrence
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- B2019-204-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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