Targeted TherapyPhase 2NCT05310331
Donafenib for Recurrent Cervical Cancer
A Phase 2 study testing Donafenib combined with paclitaxel and platinum ± PD-1 antibody in people with Targeted Therapy and Chemotherapy, run by Lei Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Targeted Therapy, Chemotherapy, Recurrent Cervical Carcinoma
- What is being tested?
- Donafenib combined with paclitaxel and platinum ± PD-1 antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2022to 27 Jun 2024
- Phase
- Phase 2
- 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
- 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.
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- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, M.D., 8613911988831, lileigh@163.com
About this study
Official title: Efficacy and Safety of Donafenib Combined With Paclitaxel and Platinum in Patients With Recurrent, Metastatic, and Persistent Advanced Cervical Cancer: A Single-arm, Phase II Study
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.
Read the detailed description
This is a single center, non-randomized, open-label Phase II clinical study to investigate the efficacy and tolerability of Donafenib combined with paclitaxel and platinum ± PD-1 antibody in patients with recurrent cervical cancer. In total 20 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.
Actual Study Start Date: March 27, 2022 Estimated Primary Completion Date: December 27, 2023 Estimated Study Completion Date: June 27, 2024
Arms There is only one arm, i.e., group of Donafenib combined with paclitaxel and platinum ± PD-1 antibody. Each treatment period was 21 days. Patients will be treated with 4-6 cycles of Donafenib plus TP or TC ± PD-1 antibody. After completion of the combination, patients will be maintained on Donafenib until disease progression or unacceptable toxicity occurs (up to 12 months)
Donafenib was taken orally at 200 mg twice on an empty stomach (1 hour before or > 2 hours after meal) in the morning and evening of each administration day, with an interval of about 12 hours. Maintain the same dose until disease progression, death, toxicity intolerance, withdrawal of informed consent, initiation of new antineoplastic therapy, or termination of treatment for other reasons specified in the protocol, for a maximum of 12 months.
Paclitaxel and platinum:
If creatinine clearance rate > 60ml/min: on Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of paclitaxel 135 mg/m2plus cisplatin 50 mg/m2.
If 40ml/min < creatinine clearance rate < 60ml/min:on Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of paclitaxel 175 mg/m2 plus carboplatin AUC=5.
PD-1 antibody: PD-1 antibody is not mandatory, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle until disease progression, death, toxicity intolerance, withdrawal of informed consent, initiation of new antitumor therapy, or termination of treatment for other reasons specified in the protocol, the longest treatment period is 12 months.
The primary outcome measure is progression-free survival. The secondary outcome measures include overall survival, objective response rate, etc.
- Conditions
- Targeted Therapy, Chemotherapy, Recurrent Cervical Carcinoma, Metastatic Cervical Carcinoma, Persistent Advanced Cervical Carcinoma, Survival Outcomes
- Being tested
- Donafenib combined with paclitaxel and platinum ± PD-1 antibody
- 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.
Donafenib combined with paclitaxel and platinum ± PD-1 antibodyCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with recurrent cervical cancer | Experimental | Eligible patients according to inclusion and exclusion criteria. Receives: Combination Product: Donafenib combined with paclitaxel and platinum ± PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (4)
Overall survival
Overall survival is defined as the duration from date of enrollment to the date of death from any cause.
Measured: 36 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants in the analysis population who have a complete or partial remission.
Measured: 24 months
Duration of Response (DCR)
DCR is defined as the percentage of participants in the analysis population who have a complete or partial remission, or stable disease (SD).
Measured: 24 months
Adverse Events
Adverse event (AE)、Treatment emergent adverse event (TEAE)、Serious adverse event (SAE).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start27 Mar 2022
- Primary completion27 Dec 2023 (estimated)
- Study completion27 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Targeted TherapyStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310331
- Sponsor's protocol ID
- DONA1
- Status last verified
- Mar 2022
- First submitted
- 26 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Donafenib Combined With Paclitaxel and Platinum in Patients With Recurrent, Metastatic, and Persistent Advanced Cervical Cancer: A Single-arm, Phase II Study
- ClinicalTrials.gov ID
- NCT05310331
- Acronym / sponsor ID
- DONA1
- Conditions
- Targeted Therapy, Chemotherapy, Recurrent Cervical Carcinoma, Metastatic Cervical Carcinoma, Persistent Advanced Cervical Carcinoma, Survival Outcomes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 27 Mar 2022 (actual)
- Primary completion
- 27 Dec 2023 (estimated)
- Study completion
- 27 Jun 2024 (estimated)
- First posted
- 4 Apr 2022 (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.
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.
Detailed description
This is a single center, non-randomized, open-label Phase II clinical study to investigate the efficacy and tolerability of Donafenib combined with paclitaxel and platinum ± PD-1 antibody in patients with recurrent cervical cancer. In total 20 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.
Actual Study Start Date: March 27, 2022 Estimated Primary Completion Date: December 27, 2023 Estimated Study Completion Date: June 27, 2024
Arms There is only one arm, i.e., group of Donafenib combined with paclitaxel and platinum ± PD-1 antibody. Each treatment period was 21 days. Patients will be treated with 4-6 cycles of Donafenib plus TP or TC ± PD-1 antibody. After completion of the combination, patients will be maintained on Donafenib until disease progression or unacceptable toxicity occurs (up to 12 months)
Donafenib was taken orally at 200 mg twice on an empty stomach (1 hour before or > 2 hours after meal) in the morning and evening of each administration day, with an interval of about 12 hours. Maintain the same dose until disease progression, death, toxicity intolerance, withdrawal of informed consent, initiation of new antineoplastic therapy, or termination of treatment for other reasons specified in the protocol, for a maximum of 12 months.
Paclitaxel and platinum:
If creatinine clearance rate > 60ml/min: on Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of paclitaxel 135 mg/m2plus cisplatin 50 mg/m2.
If 40ml/min < creatinine clearance rate < 60ml/min:on Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of paclitaxel 175 mg/m2 plus carboplatin AUC=5.
PD-1 antibody: PD-1 antibody is not mandatory, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle until disease progression, death, toxicity intolerance, withdrawal of informed consent, initiation of new antitumor therapy, or termination of treatment for other reasons specified in the protocol, the longest treatment period is 12 months.
The primary outcome measure is progression-free survival. The secondary outcome measures include overall survival, objective response rate, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with recurrent cervical cancer | Experimental | Combination Product: Donafenib combined with paclitaxel and platinum ± PD-1 antibodyEligible patients according to inclusion and exclusion criteria. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donafenib combined with paclitaxel and platinum ± PD-1 antibodyPatients 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. | Combination product | Patients with recurrent cervical cancer |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 24 months
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.
4 secondary outcomes
Overall survival
Time frame: 36 months
Objective Response Rate (ORR)
Time frame: 24 months
Duration of Response (DCR)
Time frame: 24 months
Adverse Events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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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.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donafenib combined with paclitaxel and platinum ± PD-1 antibody in people with Targeted Therapy and Chemotherapy, run by Lei Li 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 9 inclusion and 12 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 4 Apr 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lei Li, M.D. (86-139-1198-8831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 24 months). 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 4 Apr 2022.