Objective Response RatePhase 2NCT04670978
Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ovarian Cancer
A Phase 2 study testing albumin-bound paclitaxe combined with bevacizumab biosimilar in people with Objective Response Rate, run by Shandong University at 1 site in China.
Trial summary
The study is a multi-center, prospective, one-arm, phase II clinical trial. It is tend to examine the safety and efficacy of combining abraxane(albumin-bound paclitaxel） and bevacizumab to treat patients with recurrent, platinum-resistant primary epithelial ovarian cancer, fallopian tube cancer or peritoneal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Objective Response Rate
- What is being tested?
- albumin-bound paclitaxe combined with bevacizumab biosimilar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2021to 31 Dec 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent or progressive primary EOC, fallopian tube carcinoma or peritoneal carcinoma (PC) within 6 months of their last previous platinum therapy
- Patients had received at least one prior line of platinum-based chemotherapy
- Patients were required to have one measurable disease for assessment according to RECIST version 1.1 or determined CA125 level according to GCIG
- Eastern Cooperative Oncology Group (ECOG) Performance Status rating of 0-1
- life expectancy ≥3 months
- ≥30 days after surgery, the body has recovered and there is no active infection
Show all 10Show fewer
- Patients had received at least 1 prior line of platinum-based chemotherapy and were recurrent or progressed within 6 months after the end of the last platinum-based regimen
- Must have adequate hematologic and hepatic function
- Subjects of childbearing age must agree to use effective contraception during the trial period and negative for serum or urine pregnancy test
- Patient provides voluntary written informed consent
Who cannot join
- Previously received bevacizumab.
- History of other invasive malignancy with the exception of nonmelanoma skin cancer
- Participate in other drug trials
- Blood pressure of >150/100 mmHg on antihypertensive medications
- Previous history of hypertensive crisis or hypertensive encephalopathy
- Diagnosed with unstable angina per NYHA or Grade 2 or greater congestive heart failure
Show all 24Show fewer
- The history of myocardial infarction within 6 months
- The history of stroke or transient ischemic attack within 6 months of enrollment
- Clinically significant vascular disease (e.g., aortic aneurysm, aortic dissection) or symptomatic peripheral vascular disease
- Bleeding diathesis or coagulopathy
- Presence of central nervous system or brain metastases
- Pre-existing peripheral neuropathy of Grade ≥ 2
- Major surgery was performed within 28 days prior to enrollment
- Partial or complete ileus within 3 months prior to study enrollment
- A biopsy or other minor surgery within 7 days prior to study enrollment
- Positive pregnancy test or is lactating
- Abdominal fistula, gastrointestinal perforation or abscess accumulation in the abdominal cavity within 6 months prior to study enrollment
- Severe, nonhealing wound, ulcer, or bone fracture
- Serious intercurrent medical or psychiatric illness, including serious active infection
- Uncontrolled systemic infections require antiinfective treatment
- Proteinuria at screening as demonstrated by either
- Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening OR
- Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible)
- Known to be allergic, highly sensitive or intolerant to investigational drugs or their excipients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Beihua Kong, MD. PhD., +8618560081888, kongbeihua@sdu.edu.cn
About this study
Official title: Efficacy and Safety of Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ovarian Cancer：A Multi-center, Prospective, One-arm, Phase II Study
The study is a multi-center, prospective, one-arm, phase II clinical trial. It is tend to examine the safety and efficacy of combining abraxane(albumin-bound paclitaxel） and bevacizumab to treat patients with recurrent, platinum-resistant primary epithelial ovarian cancer, fallopian tube cancer or peritoneal carcinoma.
- Conditions
- Objective Response Rate
- Being tested
- albumin-bound paclitaxe combined with bevacizumab biosimilar
- Keywords
- epithelial ovarian cancer, platinum-resistant recurrent, Abraxane, Bevacizumab Biosimilar
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albumin-bound paclitaxe combined with bevacizumab biosimilarDrug
albumin-bound paclitaxe, 260mg/m2, every 3 weeks, 6cycles, bevacizumab biosimilar, 10mg/kg, every 3 weeks, continue until PD or unaccceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| albumin-bound paclitaxe combined with bevacizumab biosimilar | Experimental | albumin-bound paclitaxel, 260mg/m2，ivdrip，D1，once every three weeks bevacizumab biosimilar, 10mg/kg，ivdrip，D1, once every three weeks Receives: Drug: albumin-bound paclitaxe combined with bevacizumab biosimilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; objective response rate (ORR) = CR+PR
Measured: Assessed at the end of 6 cycle(each cycle is 21 days)
Secondary outcomes (4)
6-month progression-free survival rate
the percentage of participants with no progression event at 6 months after starting study treatment
Measured: assessed up to 6 months
progression-free survival
PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first
Measured: up to 3 years
overall survival
Overall survival is defined as the time from treatment start until death from any cause
Measured: assessed up to 3 years
Disease control rate
the percentage of complete and partial response as well as stable disease
Measured: Assessed at the end of 6 cycle(each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start31 Mar 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Objective Response RateStudies 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beihua Kong, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670978
- Sponsor's protocol ID
- AB-PRR-EOC
- Status last verified
- Apr 2023
- First submitted
- 5 Dec 2020
- Last updated
- 25 Apr 2023
- 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 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ovarian Cancer：A Multi-center, Prospective, One-arm, Phase II Study
- ClinicalTrials.gov ID
- NCT04670978
- Acronym / sponsor ID
- AB-PRR-EOC
- Conditions
- Objective Response Rate
- Keywords
- epithelial ovarian cancer, platinum-resistant recurrent, Abraxane, Bevacizumab Biosimilar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Dec 2020 (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.
The study is a multi-center, prospective, one-arm, phase II clinical trial. It is tend to examine the safety and efficacy of combining abraxane(albumin-bound paclitaxel） and bevacizumab to treat patients with recurrent, platinum-resistant primary epithelial ovarian cancer, fallopian tube cancer or peritoneal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| albumin-bound paclitaxe combined with bevacizumab biosimilar | Experimental | Drug: albumin-bound paclitaxe combined with bevacizumab biosimilaralbumin-bound paclitaxel, 260mg/m2，ivdrip，D1，once every three weeks bevacizumab biosimilar, 10mg/kg，ivdrip，D1, once every three weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Recurrent or progressive primary EOC, fallopian tube carcinoma or peritoneal carcinoma (PC) within 6 months of their last previous platinum therapy
- Patients had received at least one prior line of platinum-based chemotherapy
- Patients were required to have one measurable disease for assessment according to RECIST version 1.1 or determined CA125 level according to GCIG
- Eastern Cooperative Oncology Group (ECOG) Performance Status rating of 0-1
- life expectancy ≥3 months
Key exclusion criteria (24 listed)
- Previously received bevacizumab.
- History of other invasive malignancy with the exception of nonmelanoma skin cancer
- Participate in other drug trials
- Blood pressure of >150/100 mmHg on antihypertensive medications
- Previous history of hypertensive crisis or hypertensive encephalopathy
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 |
|---|---|---|
| albumin-bound paclitaxe combined with bevacizumab biosimilaralbumin-bound paclitaxe, 260mg/m2, every 3 weeks, 6cycles, bevacizumab biosimilar, 10mg/kg, every 3 weeks, continue until PD or unaccceptable toxicity | Drug | albumin-bound paclitaxe combined with bevacizumab biosimilar |
Primary outcome
objective response rate
Time frame: Assessed at the end of 6 cycle(each cycle is 21 days)
Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; objective response rate (ORR) = CR+PR
4 secondary outcomes
6-month progression-free survival rate
Time frame: assessed up to 6 months
progression-free survival
Time frame: up to 3 years
overall survival
Time frame: assessed up to 3 years
Disease control rate
Time frame: Assessed at the end of 6 cycle(each cycle is 21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Objective Response Rate
Recruiting
Adebrelimab Combined With Chemotherapy for the Esophageal Squamous Cell Carcinoma
Pathological Complete Remission, Objective Response Rate
Not yet recruitingPhase 2
Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Immunotherapy for Head and Neck Squamous Cell Carcinoma Invading the Skull Base
Head and Neck Cancer Squamous Cell Carcinoma, Skull Base--Cancer
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.
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 albumin-bound paclitaxe combined with bevacizumab biosimilar in people with Objective Response Rate, run by Shandong University 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 10 inclusion and 24 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 25 Apr 2023. 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 Beihua Kong (18560081888, kongbeihua@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: Assessed at the end of 6 cycle(each cycle is 21 days)). 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 25 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.