Uterine Cervical NeoplasmsNCT04695535
Chemotherapy With Anlotinib in Advanced Cervical Cancer
An observational study of Uterine Cervical Neoplasms, run by Yang Shen at 1 site in China.
Trial summary
STUDY HYPOTHESIS: The primary hypothesis is whether chemotherapy with Anlotinib improves overall survival in advanced cervical cancer. TRIAL DESIGN: The study is a prospective, single-arm, observational clinical study. The study will be performed on an intent-to-treat population. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2019to Jun 2022
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced (metastatic, persistent, and recurrent) cervical cancer
Who may be able to join
- Patients with advanced (metastatic, persistent, and recurrent) cervical cancer confirmed by imaging and unsuitable for surgery and radiotherapy .
- Eastern Cooperative Oncology Group (ECOG) Performance Score(PS) 0-1
- Estimated life expectancy > 3 months
- Adequate bone marrow function: hemoglobin > 90 g/L, absolute neutrophil count(ANC) > 1.5 × 10^9/L, platelet > 80 × 10^9/L);
- Adequate hepatic function: total bilirubin < 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<2.5×ULN or <5×ULN for patients with liver metastases;
- Adequate renal function: serum creatinine < 1.5 × ULN or creatinine clearance rate (CCR) >60 mL/min;
- Adequate cardiac function: left ventricular ejection fraction (LVEF) > 50%.
Who cannot join
- Preexisting thyroid disease, thyroid function cannot be maintained in the normal range after treatment;
- Have used other anti-VEGF or VEGFR-targeted drugs or received immunotherapy;
- A history of major surgical treatment within 4 weeks, radiotherapy within 3 weeks, and concurrent chemoradiotherapy within 6 weeks;
- Receiving hormone or immunosuppressive therapy for various reasons;
- Inability to swallow oral medication;
- Any malabsorption;
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- Diseases diagnosed as severe or uncontrollable within 6 months prior to the first day of treatment.
- Participate in clinical trials of other antitumor drugs within 28 days prior to the start of study treatment;
- The patient has comorbidities that may endanger the patient's safety or affect the patient's ability to complete the study.
- According to the researcher's judgment, the patient has an accompanying disease that may jeopardize the patient's safety or affect the patient's ability to complete the study in the investigator's judgment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital, Affiliated to Southeast University
Nanjing, Jiangsu, 210029
Zhao Tao, 025-83272064, 13057632365@126.com
About this study
Official title: Chemotherapy With Anlotinib in Advanced Cervical Cancer: A Prospective, Single-arm Study
STUDY HYPOTHESIS: The primary hypothesis is whether chemotherapy with Anlotinib improves overall survival in advanced cervical cancer.
TRIAL DESIGN: The study is a prospective, single-arm, observational clinical study. The study will be performed on an intent-to-treat population. All the enrolled patients received chemotherapy with Anlotinib.
PRIMARY ENDPOINT: Overall survival, defined as the observed length of life from entry into the study to death from any cause or the date of last contact.
Read the detailed description
Patients with advanced (metastatic, persistent, and recurrent) cervical cancer will be recruited from Zhongda Hospital. Only patients who treated with paclitaxel plus nedaplatin will be included in the analysis. All patients receive paclitaxel (135-175mg /m^2) and nedaplatin (100 mg/m^2) infusion on day 1, and then take Anlotinib 12mg/d orally on day 7-21, every 3 weeks. Once patients reached CR or PR, Anlotinib was continued on 12mg/d maintenance therapy until disease progression or unacceptable toxicity was noted.
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Anlotinib, Chemotherapy, Advanced Cervical Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Chemotherapy with Anlotinib | Patients received chemotherapy with Anlotinib. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The time from the first day of treatment until death from any cause
Measured: Up to 3 years
Secondary outcomes (3)
Progression-free survival
The time from the first day of treatment until disease progression or death from any cause, or as the date of the last follow-up.
Measured: Up to 3 years
Incidence of Adverse Events [Safety and Tolerability]
Adverse Events were assessed according to the National Cancer Institute's Common Toxicity Criteria (CTCAE) version 4.0.
Measured: Up to 3 years
The average score of FACT-Cx TOI [Functional Assessment]
The HRQL instruments used in this trial were the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI), for which a higher score indicates better HRQL.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start20 May 2019
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yang Shen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Shen, Zhongda Hospital
- Investigators
- Yang Shen, MD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695535
- Sponsor's protocol ID
- ZhongdaH-YShen
- Status last verified
- Jan 2021
- First submitted
- 28 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy With Anlotinib in Advanced Cervical Cancer: A Prospective, Single-arm Study
- ClinicalTrials.gov ID
- NCT04695535
- Acronym / sponsor ID
- ZhongdaH-YShen
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Anlotinib, Chemotherapy, Advanced Cervical Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yang ShenUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
STUDY HYPOTHESIS: The primary hypothesis is whether chemotherapy with Anlotinib improves overall survival in advanced cervical cancer.
TRIAL DESIGN: The study is a prospective, single-arm, observational clinical study. The study will be performed on an intent-to-treat population. All the enrolled patients received chemotherapy with Anlotinib.
PRIMARY ENDPOINT: Overall survival, defined as the observed length of life from entry into the study to death from any cause or the date of last contact.
Detailed description
Patients with advanced (metastatic, persistent, and recurrent) cervical cancer will be recruited from Zhongda Hospital. Only patients who treated with paclitaxel plus nedaplatin will be included in the analysis. All patients receive paclitaxel (135-175mg /m^2) and nedaplatin (100 mg/m^2) infusion on day 1, and then take Anlotinib 12mg/d orally on day 7-21, every 3 weeks. Once patients reached CR or PR, Anlotinib was continued on 12mg/d maintenance therapy until disease progression or unacceptable toxicity was noted.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy with Anlotinib | – | –Patients received chemotherapy with Anlotinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced (metastatic, persistent, and recurrent) cervical cancer
Key inclusion criteria (7 listed)
- Patients with advanced (metastatic, persistent, and recurrent) cervical cancer confirmed by imaging and unsuitable for surgery and radiotherapy .
- Eastern Cooperative Oncology Group (ECOG) Performance Score(PS) 0-1
- Estimated life expectancy > 3 months
- Adequate bone marrow function: hemoglobin > 90 g/L, absolute neutrophil count(ANC) > 1.5 × 10^9/L, platelet > 80 × 10^9/L);
- Adequate hepatic function: total bilirubin < 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<2.5×ULN or <5×ULN for patients with liver metastases;
Key exclusion criteria (10 listed)
- Preexisting thyroid disease, thyroid function cannot be maintained in the normal range after treatment;
- Have used other anti-VEGF or VEGFR-targeted drugs or received immunotherapy;
- A history of major surgical treatment within 4 weeks, radiotherapy within 3 weeks, and concurrent chemoradiotherapy within 6 weeks;
- Receiving hormone or immunosuppressive therapy for various reasons;
- Inability to swallow oral medication;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: Up to 3 years
The time from the first day of treatment until death from any cause
3 secondary outcomes
Progression-free survival
Time frame: Up to 3 years
Incidence of Adverse Events [Safety and Tolerability]
Time frame: Up to 3 years
The average score of FACT-Cx TOI [Functional Assessment]
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Shen, MD principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervical Neoplasms, run by Yang Shen 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 7 inclusion and 10 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 5 Jan 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.
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 Shen, MD (025-83262742, shenyang0924@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2021.