- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04731038
Combination Therapy for First Line Treatment of Advanced Cervical Cancer
September 16, 2021 updated by: Jun Zhang, Ruijin Hospital
Combination of Paclitaxel, Cisplatin\Carboplatin With Toripalimab and Anlotinib for First Line Treatment of Advanced Cervical Cancer
This is a single center phase 1 trail to observe safety and efficacy of Paclitaxel plus Cisplatin\Carboplatin, PD-L1 antibody Toripalimab and Anlotinib as first-line regimen to treat the patient with metastatic 、persistent or recurrent disease after radical surgery、radical platinum-based concurrent chemoradiotherapy or both (Stage IA-IVA).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Advanced cervical cancer patients with metastatic, persistent or recurrent disease after radical surgery、radical platinum-based concurrent chemoradiotherapy or both will be treated by Paclitaxel plus Cisplatin\Carboplatin, PD-L1 antibody Toripalimab and Anlotinib.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wenqi Xi
- Phone Number: +86-13601782226
- Email: xwq11061@rjh.com.cn
Study Locations
-
-
-
Shanghai, China, 200025
- Recruiting
- Department of Oncology, Ruijin Hospital
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- female patients aged≥18 years.
- Histologically confirmed cervical squamous cell carcinoma or adenocarcinoma, without uncontrolled pleural effusion or ascites.
- Patients with advanced or metastatic disease who have disease progression after radical surgery、radical platinum-based concurrent chemoradiotherapy or both (Stage IA-IVA), with measurable lesions.
- ECOG performance status 0 or 2, expected lifetime≥3 months.
- Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥100x109/L, Hemoglobin (Hb) ≥100g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤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.
Exclusion Criteria:
- 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
- Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction).
- known hypersensitivity reaction to any of the study drugs or components.
- Other unsuitable conditions determined by investigators.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Anlotinib 12mg qd.
po.
d1-d14 q3w Toripalimab 240mg ivgtt.
d1 q3w Paclitaxel 135mg/m2 ivgtt.
d1 q3w Cisplatin 50mg/m2 ivgtt.
d1 q3w Carboplatin AUC=5 ivgtt.
d1 q3w
|
This is a single-arm study with all patients receiving these four drugs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: adverse events as assessed by CTCAE v5.0
Time Frame: 36 months
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 36 months
|
36 months
|
Progression free survival
Time Frame: 36 months
|
36 months
|
Objective response rate
Time Frame: 36 months
|
36 months
|
Disease control rate
Time Frame: 36 months
|
36 months
|
Duration of response
Time Frame: 36 months
|
36 months
|
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)
August 1, 2021
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
July 1, 2024
Study Registration Dates
First Submitted
January 27, 2021
First Submitted That Met QC Criteria
January 27, 2021
First Posted (Actual)
January 29, 2021
Study Record Updates
Last Update Posted (Actual)
September 17, 2021
Last Update Submitted That Met QC Criteria
September 16, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Uterine Cervical Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
- Cisplatin
Other Study ID Numbers
- COMSTRAIN-CESC
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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