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Uterine Cervical NeoplasmsNCT04772001

Concurrent Radiochemotherapy Plus Anlotinib for Locally Advanced Cervical Cancer

A study testing Hydrochloride anlotinib, cis Platinum/carboplatin and External beam radiotherapy and brachytherapy in people with Uterine Cervical Neoplasms and Chemoradiotherapy, run by Zhongnan 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To observe the efficacy and safety of hydrochloride anlotinib combined with concurrent radiochemotherapy for patients with FIGO stage IB3 and IIA2-IVA cervical cancer. Patient characteristics, image and genetic information of tumor, microbial sample of tumor microenvironment and biomarker in the blood sample will be… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Hydrochloride anlotinib, cis Platinum/carboplatin and External beam radiotherapy and brachytherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteChina
Study dates
12 Mar 2021to Jan 2026
Phase
Interventional
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years old and ≤75 years old;
  • ECOG PS score 0-2 points;
  • After pathological examination, it is clear that it is cervical cancer, the pathological types include squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma;
  • The staging conforms to the definitions of IB3 and IIA2-IVA in FIGO2018;
  • The expected survival period is ≥6 months;
  • The lesion meets the requirements of RECIST 1.1 for evaluable lesions;
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  • Have not received any form of anti-tumor treatment before joining the group (except for partial cervical biopsy resection);
  • Expect to tolerate radiotherapy;
  • It is expected to tolerate concurrent chemotherapy with platinum drugs;
  • It is expected to tolerate oral Anlotinib treatment;
  • The sitting blood pressure at rest is less than the normal high value (<140/90mmHg), or the average blood pressure of the 24-hour ambulatory blood pressure monitoring is less than the normal high value (<140/90mmHg), regardless of whether you are taking antihypertensive drugs or not;
  • Hematology indicators meet (no blood transfusion and no correction with hematopoietic stimulating factor drugs within 7 days before screening): white blood cell count (WBC) ≥3.5×109/L and ≤10×109/L, neutrophil count ( ANC) ≥1.5×109/L, platelet (PLT) ≥125×109/L, hemoglobin (Hb) ≥90g/L;
  • The liver function index meets: ALT and AST≤2.5 times high normal value (ULN), bilirubin≤1.5×ULN, albumin≥35g/L;
  • The coagulation function index meets (not receiving anticoagulation or drug hemostasis treatment): PT and APTT ≤ 1.5×ULN, and INR ≤ 1.5 ULN;
  • Renal function indicators meet: urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN and creatinine clearance ≥60 mL/min (Cockcroft-Gault formula), urine protein <2+ or 24-hour urine protein quantitative <1g
  • Women of childbearing age must undergo a serum pregnancy study within 7 days before the first medication, and the result is negative, and they are not breastfeeding. Female subjects of childbearing age must agree to use effective methods of contraception during the study period and within 180 days after the last administration of the study drug;
  • Obtain informed consent signed by the patient or his legal representative;
  • Have good compliance.

Who cannot join

  • Any unstable systemic disease, including but not limited to active infection within 4 weeks (defined as fever with a body temperature exceeding 38.5℃ or clear evidence of bacteremia or evidence of heart, brain, kidney, lung, etc.) Infectious changes in the liver and intestines), circulatory accidents within 6 months (malignant hypertension, myocardial infarction, severe/unstable angina pectoris, heart insufficiency above NYHA level 2, clinically significant supraventricular or Ventricular arrhythmia, cerebrovascular accident that has not recovered or caused serious sequelae), uncontrolled type 2 diabetes (fasting blood glucose> 11.1mmol/L or glycosylated hemoglobin> 8%), lung insufficiency (pulmonary function caused by any reason Decrease, defined as lung function test FEV1/FVC<70%, FEV1<80% predicted value).
  • Past autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune liver disease, autoimmune thyroiditis, systemic vasculitis, scleroderma, dermatomyositis, self Immune hemolytic anemia;
  • Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; hepatitis C, defined as HCV -RNA is higher than the detection limit of the analysis method) or combined with hepatitis B and C infection;
  • The history of live attenuated vaccine vaccination within 28 days before the first study medication or the expected live attenuated vaccine vaccination during the study period;
  • Imaging shows that the tumor invades large blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study or other diseases with serious bleeding risk (the bleeding caused by simple cervical tumor rupture is not included)
  • Previously received anti-angiogenesis targeted drug therapy, or other treatments for VEGFR inhibitors;
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  • There is evidence of active tuberculosis infection within 1 year before screening;
  • Any other malignant tumor has been diagnosed within 5 years before entering the study, except for fully treated basal cell carcinoma or squamous cell skin cancer or cervical carcinoma in situ;
  • Major surgery has been performed within 28 days before randomization (tissue biopsy required for diagnosis and central venous catheter insertion via peripheral venipuncture [PICC] are allowed);
  • Arteriovenous thrombosis events that occurred within 6 months before randomization, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis (venous thrombosis caused by intravenous catheterization due to pre-chemotherapy, which has been cured by the investigator Except) and pulmonary embolism;
  • Subjects who have previously received or plan to receive allogeneic bone marrow transplantation or solid organ transplantation;
  • There is intestinal obstruction with significant clinical significance, intestinal repair, intestinal anastomosis or intestinal fistula occurs at any time for any reason;
  • Subjects with symptoms of hemoptysis and the maximum daily volume of hemoptysis ≥2.5 mL within 2 months before entering the study. Have had significant clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months before entering the study, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline stool occult blood++ or above, or suffering from vasculitis, etc.; Known to have inherited or acquired bleeding and thrombotic tendency, such as: hemophilia, blood coagulation disorder, thrombocytopenia, hypersplenism, etc.;
  • Macroscopic hematuria or urinary bleeding indicated by other evidence;
  • Are receiving thrombolysis or need long-term anticoagulation therapy with warfarin or heparin, or need long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day)
  • Peripheral neuropathy ≥ Grade 2;
  • Intolerance to platinum chemotherapy drugs (including intolerance caused by allergies or other physical symptoms);
  • Kidney stones at risk of seizure, one kidney has no function or anatomically single kidney;
  • Long-term bed rest for any reason;
  • Cachexia state;
  • Known allergy to Anlotinib or any of its excipients;
  • Those who have other anti-tumor treatment plan during treatment;
  • Participated in any other drug clinical research within 4 weeks before randomization, or no more than 5 half-lives from the last study drug;
  • The subject is known to have a history of psychotropic drug abuse, alcohol abuse or drug abuse;
  • Those who have a mental illness that seriously affects cognition and cannot achieve a stable mental state;
  • According to the judgment of the investigator, the patient may have other factors that may cause the study to be terminated halfway, such as other serious diseases or severe laboratory abnormalities or other factors that will affect the safety of the subjects, or test data And the family or society where the sample was collected

Trial locations and contacts

1 site in 1 country.

Shaoxing Sun, M. D. contact

+8613871286154

sunshaoxing@whu.edu.cn

China1 site, 1 recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

    Shaoxing Sun, +8613871286154, sunshaoxing@whu.edu.cn

    Hui Qiu, +8618986255160, qiuhuiznyy@whu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Clinical Study of Hydrochloride Anlotinib Combined With Concurrent Radiochemotherapy for Locally Advanced (Stage IB3 and IIA2-IVA) Cervical Cancer

To observe the efficacy and safety of hydrochloride anlotinib combined with concurrent radiochemotherapy for patients with FIGO stage IB3 and IIA2-IVA cervical cancer. Patient characteristics, image and genetic information of tumor, microbial sample of tumor microenvironment and biomarker in the blood sample will be collected and analysis by multi-omics and bioinformatic technology. Aim to provide a new treatment module for cervical cancer.

Read the detailed description

Patients diagnosed pathologically as cervical cancer (squamous carcinoma, adenocarcinoma or adenosquamous carcinoma) with stage of FIGO IB3 and IIA2 to IVB will be included in this study according to the prescribed criteria in the protocal. Classical radiochemotherapy will be conducted by clinical routine method. Radiation will be given by external beam radiation of 45Gy total dose and 3D-brachytherapy of 30Gy/5F or 28Gy/4F. Duration of radiotherapy will be no more than 8 weeks. Concurrent chemotherapy will be administrated weekly during radiation for a total of 5-6 doses. Cisplatin of 40mg/m2 will be the most preferred regime and for patients with intolerable toxicity of cisplatin, carboplatin of AUC 2 will be the alternative drug. Apart from that, hydrochloride anlotinib, a multiple targets anti-angiogenesis kinase approved by CFDA, will be orally taken daily at a dose of 12mg for 14 days aiming to improve tumor response. Then rest for 7 days and start a new cycles for a total of 3 cycles. First capsule of anlotinib will be taken 7 days before the first radiation. Once the treatment is finished, patients will be examination for tumor evaluation and toxicity monitor every 3 months for the first 2 years and then every half years for the third year unless progression or death. During those period, patient characteristics, image data, tumor tissue, blood, urine, stool and microbial sample of tumor micro environment will be collected and analysis by multi-omics and bioinformatic technology. A total of 53 patients will be included and this study will be conducted in the department of radiation and clinical oncology in Zhongnan Hospital of Wuhan University.

Being tested
Hydrochloride anlotinib, cis Platinum/carboplatin, External beam radiotherapy and brachytherapy
Keywords
Uterine Cervical Neoplasms, Chemoradiotherapy, Anlotinib
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.

  • Hydrochloride anlotinibDrug

    Hydrochloride anlotinib is a small molecular anti-angiogenesis drug with multiple targets. It will be taken at a starting dose of 12 mg for 14 days. Then participants will rest for 7 days and start a new cycles. At most of 3 cycles will be administrated. If intolerable toxicity happen, dosage of 10mg or 8mg will be taken.

  • cis Platinum/carboplatinDrug

    Concurrent chemotherapy will be administrated weekly during radiation for a total of 5-6 doses. Cisplatin of 40mg/m2 will be the most preferred regime. For patients with intolerable toxicity of cisplatin, carboplatin of AUC 2 will be the alternative drug.

  • External beam radiotherapy and brachytherapyRadiation

    Radiation will be given by external beam of 45Gy total dose and 3D-brachytherapy of 30Gy/5F or 28Gy/4F. Duration of radiotherapy will be no more than 8 weeks.

Study groups in NCT04772001
Study groupRoleWhat they receive
CCRT+AnlotinibExperimentalClassical chemoradiotherapy will be conducted by clinical routine method. Radiation will be given by external beam of 45Gy total dose and 3D-brachytherapy of 30Gy/5F or 28Gy/4F. Duration of radiotherapy will be no more than 8 weeks. Concurrent chemotherapy will be administrated weekly during radiation for a total of 5-6 doses. Cisplatin of 40mg/m2 will be the most preferred regime and for patients with intolerable toxicity of cisplatin, carboplatin of AUC 2 will be the alternative drug. Hydrochloride anlotinib will be orally taken daily at a dose level of 12mg for 14 days. Then rest for 7 days and start a new cycles for a total of 3 cycles. First capsule of anlotinib will be taken 7 days before the first radiation.
Receives: Drug: Hydrochloride anlotinib; Drug: cis Platinum/carboplatin; Radiation: External beam radiotherapy and brachytherapy

What is being measured

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

  1. 3 years disease free survival rate

    Proportion of participants without tumor recurrence or death at 3 years from enrollment

    Measured: 3 years from enrollment

Secondary outcomes (9)

  1. Adverse events

    Adverse events data according to CTCAE version 5.0

    Measured: From enrollment to 90 days after treatment finish

  2. 3 years overall survival rate

    Proportion of survival participants at 3 years from enrollment

    Measured: 3 years from enrollment

  3. Objective response rate

    Proportion of participants with complete response and partial response

    Measured: 5 years from enrollment

  4. Disease control rate

    Proportion of participants with complete response, partial response and stable disease

    Measured: 5 years from enrollment

  5. 5 years progression free survival rate

    Proportion of participants without tumor progression or death at 3 years from enrollment

    Measured: 5 years from enrollment

  6. 5 years overall survival rate

    Proportion of survival participants at 5 years from enrollment

    Measured: 5 years from enrollment

  7. Median overall survival

    Median survival time of all participants from enrollment to death of any reason

    Measured: 5 years of follow-up

  8. Median progression free survival

    Median time of all participants from enrollment to tumor progression

    Measured: 5 years of follow-up

  9. Score of life quality

    European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire. Scores ranging from 0 to 100, higher scores indicating better functioning.

    Measured: 3 years from enrollment

Timeline

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

  1. First posted25 Feb 2021
  2. Study start12 Mar 2021
  3. Primary completionOct 2025 (estimated)
  4. Study completionJan 2026 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will be included in one arm and receive chemoradiotherapy and anlotinib according to the protocol
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04772001
Sponsor's protocol ID
CC-RT-ALTER-01
Status last verified
May 2022
First submitted
19 Feb 2021
Last updated
18 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Krill LS, Tewari KS. Integration of bevacizumab with chemotherapy doublets for advanced cervical cancer. Expert Opin Pharmacother. 2015 Apr;16(5):675-83. doi: 10.1517/14656566.2015.1010511. Epub 2015 Feb 3.

    PubMed 25643984

  • Monk BJ, Sill MW, Burger RA, Gray HJ, Buekers TE, Roman LD. Phase II trial of bevacizumab in the treatment of persistent or recurrent squamous cell carcinoma of the cervix: a gynecologic oncology group study. J Clin Oncol. 2009 Mar 1;27(7):1069-74. doi: 10.1200/JCO.2008.18.9043. Epub 2009 Jan 12.

    PubMed 19139430

  • Schefter T, Winter K, Kwon JS, Stuhr K, Balaraj K, Yaremko BP, Small W Jr, Sause W, Gaffney D; Radiation Therapy Oncology Group (RTOG). RTOG 0417: efficacy of bevacizumab in combination with definitive radiation therapy and cisplatin chemotherapy in untreated patients with locally advanced cervical carcinoma. Int J Radiat Oncol Biol Phys. 2014 Jan 1;88(1):101-5. doi: 10.1016/j.ijrobp.2013.10.022.

    PubMed 24331655

  • Youn SH, Kim YJ, Seo SS, Kang S, Lim MC, Chang HK, Park SY, Kim JY. Effect of addition of bevacizumab to chemoradiotherapy in newly diagnosed stage IVB cervical cancer: a single institution experience in Korea. Int J Gynecol Cancer. 2020 Jun;30(6):764-771. doi: 10.1136/ijgc-2020-001200. Epub 2020 Apr 9.

    PubMed 32276937

  • Han B, Li K, Zhao Y, Li B, Cheng Y, Zhou J, Lu Y, Shi Y, Wang Z, Jiang L, Luo Y, Zhang Y, Huang C, Li Q, Wu G. Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302). Br J Cancer. 2018 Mar 6;118(5):654-661. doi: 10.1038/bjc.2017.478. Epub 2018 Feb 13.

    PubMed 29438373

Questions about this trial

What is this clinical trial studying?

A study testing Hydrochloride anlotinib, cis Platinum/carboplatin and External beam radiotherapy and brachytherapy in people with Uterine Cervical Neoplasms and Chemoradiotherapy, run by Zhongnan 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 26 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 18 May 2022. 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 Shaoxing Sun, M. D. (+8613871286154, sunshaoxing@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3 years disease free survival rate (time frame: 3 years from enrollment). 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 NCT04772001, which also lists 5 linked publications.

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 18 May 2022.

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