Donafenib for Recurrent Cervical Cancer

NCT05310331 | Unknown Phase 2

• 1 other identifier: DONA1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety and tolerability of Donafenib combined with paclitaxel and platinum ± programmed death 1 monoclonal antibody (PD-1 antibody) in patients with recurrent cervical cancer.

Conditions

Targeted Therapy; Chemotherapy; Recurrent Cervical Carcinoma; Metastatic Cervical Carcinoma; Persistent Advanced Cervical Carcinoma; Survival Outcomes; Adverse Effect

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS defined as the time the duration from date of enrollment to the first documented disease progression, or death due to any cause, whichever occurs first.

  24 months

Secondary Outcomes (4)

• Overall survival

  36 months

• Objective Response Rate (ORR)

  24 months

• Duration of Response (DCR)

  24 months

• Adverse Events

  24 months

Study Arms (1)

Patients with recurrent cervical cancer

EXPERIMENTAL

Eligible patients according to inclusion and exclusion criteria.

Combination Product: Donafenib combined with paclitaxel and platinum ± PD-1 antibody

Interventions

Donafenib combined with paclitaxel and platinum ± PD-1 antibody COMBINATION_PRODUCT

Patients will receive Donafenib (200mg, bid) combined with paclitaxel (135mg/m2) and cisplatin (creatinine clearance rate \> 60ml/min, 50 mg/m2) or paclitaxel (175 mg/m2) and carboplatin AUC=5 (40ml/min \< creatinine clearance rate \< 60ml/min) ± PD-1 antibody every 3 weeks.

Patients with recurrent cervical cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained.
• Age 18\~75, female.
• Histologically confirmed cervical squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma.
• Patients with cervical cancer recurred for the first time, and did not receive any treatment after recurrence.
• Patients must have measurable disease per RECIST 1.1.
• ECOG performance status 0 or 1, expected lifetime ≥ 3 months.
• No targeted drugs containing VEGF were used before, including but not limited to anlotinib, apatinib, bevacizumab, etc.
• Adequate organ function:
• Absolute neutrophil count (ANC) ≥ 1.5x109/L, Platelets ≥ 100x109/L, Hemoglobin (Hb) ≥ 90g/L, Bilirubin ≤ 1.5 times the upper limit of normal, ALT/AST ≤ 3x ULN (for patient with liver metastasis ALT/AST ≤ 5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance ≥ 40ml/min (calculated by Cockcroft-Gault formula); International normalized ratio (INR) ≤1.5

You may not qualify if:

• Histopathologic diagnoses of tumors other than squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma.
• With second primary malignant diseases.
• Pregnancy or children bearing potential.
• With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone).
• With uncontrollable complications.
• 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.
• Hepatitis B virus (HBV) \>2000 IU/ml or DNA ≥ 1×10\^4/ml; or hepatitis C virus (HCV) RNA ≥ 1×10\^3/ml).
• Has received a live vaccine within 4 weeks prior to the first dose of trial treatment. Note: Injection of inactivated viral vaccines against seasonal influenza are allowed.
• Has pleural effusion and ascites that require punctured and drained. However, an exception includes patients with pleural effusion and ascites who have no symptoms.
• Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results.

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

86-139-1198-8831; lileigh@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 4, 2022
• Study Start: March 27, 2022
• Primary Completion: December 27, 2023
• Study Completion: June 27, 2024
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

CN (1)