Skip to content

Arotinib hydrochloride arotinib hydrochloride capsule combined with radiotherapy and chemotherapy for locally advanced cervical cancer with high risk factors: a singlecenter, single-arm, open-label, phase II trial

Arotinib hydrochloride arotinib hydrochloride capsule combined with radiotherapy and chemotherapy for locally advanced cervical cancer with high risk factors: a singlecenter, single-arm, open-label, phase II trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044326
Enrollment
Unknown
Registered
2021-03-16
Start date
2022-08-30
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer

Interventions

Single arm:anlotinib

Sponsors

Guangxi Medical University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ? The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up; ? Female, age = 18 years old (calculated on the date of signing the informed consent form); ? Patients with low and middle differentiated cervical squamous cell carcinoma diagnosed by pathology; ? It contains one of the following high-risk factors: positive lymph nodes; Positive incisional margin; Vascular tumor thrombus; The tumor did not reach CR after standardized concurrent radiotherapy and chemotherapy (imaging, gynecological examination and tumor marker SCC were not normal); ? Or cervical adenocarcinoma diagnosed by pathology and special types such as neuroendocrine small cell carcinoma and mixed tumor; ? ECoG score: 0-1; ? The functions of important organs meet the following requirements (it is not allowed to use any blood components within the first 14 days of randomization): ? absolute neutrophil count = 1.5x10^9/l; ? platelet = 80x10^9/l; ? hemoglobin = 9g/dl; ? bilirubin = 1.5 times ULN ? alt, AST = 3 times ULN ? serum creatinine = 1.5 times ULN

Exclusion criteria

Exclusion criteria: ? Those who are unable to swallow the tablets normally, or have abnormal gastrointestinal function, which may affect the drug absorption according to the judgment of the researcher. ? Patients with hypertension who cannot be well controlled by antihypertensive drugs (systolic blood pressure = 140mmHg or diastolic blood pressure = 90mmHg). ? Abnormal coagulation function, or known hereditary or acquired bleeding tendency and thrombotic tendency; ? Distant metastasis; ? Pregnant or lactating women; ? Patients who have a history of psychotropic substance abuse and can not quit or have mental disorders; ? Patients who have participated in clinical trials of other drugs within 4 weeks; ? Those who have received VEGFR inhibitor treatment, such as apatinib, sorafenib and sunitinib; ? Severe allergic disease, history of severe drug allergy, and allergy to any component in the prescription of arotinib hydrochloride capsules; ? The investigator judges other situations that may affect the clinical research and the judgment of research results.

Design outcomes

Primary

MeasureTime frame
Disease-freesurvival time;

Secondary

MeasureTime frame
Objective response rate;Progression free survival time;Safety and tolerability;Overall Survival time;

Countries

China

Contacts

Public ContactHonglin Song

Guangxi Medical University Cancer Hospital

570435088@qq.com+86 13978819068

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026