Peritoneal AdhesionPhase 2NCT03095001
Intraperitoneal Chemotherapy Alone or in Combination With Bevacizumab for Ovarian Cancer With Peritoneal Adhesion
A Phase 2 study testing Bevacizumab, Carboplatin and paclitaxel in people with Peritoneal Adhesion, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Background: Malignant peritoneal adhesion is a common complication and prognostic factor of ovarian cancer and other primary abdominal tumors. The incidence of peritoneal adhesion in advanced primary peritoneal tumor is 32-56%, which has increased by more than 10 times in the recent decade. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Peritoneal Adhesion
- What is being tested?
- Bevacizumab, Carboplatin and paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 1 Jun 2020
- 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
- Pathologically and radiologically confirmed stage IV or postoperative recurrence ovarian cancer.
- Age of 18-70, Karnofsky score higher than 80.
- No severe functional damage of major organ, normal liver and kidney function.
- Peritoneal adhesion. (1) peritoneal adhesions diagnosed by microlaparoscopy or abdominal operations, and classification according to Nair criteria is performed. (1) must be met. (2) Peritoneal adhesion symptoms, intermittent abdominal pain, abdominal distension, nausea and vomiting, hard to pass stools or gas; (3) Peritoneal adhesion signs，abdominal distension, abdominal tenderness, reduced or absent bowel sounds; (4) B ultrasound or CT or MRI show peritoneal adhesion or adhesion-related complications.
Who cannot join
- Complete intestinal obstruction and suitable for surgery.
- Patients known to be allergic to bevacizumab or any of the components of the drug.
- Other ongoing anti-tumor treatment.
- Heart disease with significant clinical symptoms, such as: congestive heart failure, coronary heart disease with symptom, arrhythmia hardly be controlled by drugs, myocardial infarction in 6 months, or heart failure
- Active wound infection and a history of uncontrolled psychiatric illness.
- -
Trial locations and contacts
1 site in 1 country.
Nan Du, PhD contact
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100048
Hui Zhao, Phd
Nan Du, Phd
About this study
Official title: Chinese PLA Generation Hospital
Background: Malignant peritoneal adhesion is a common complication and prognostic factor of ovarian cancer and other primary abdominal tumors. The incidence of peritoneal adhesion in advanced primary peritoneal tumor is 32-56%, which has increased by more than 10 times in the recent decade. Malignant peritoneal adhesion is closely associated with the morbidity and mortality of malignant intestinal obstruction. The peritoneal adhesion may aggravates the abdominal symptoms and reduce quality of life. Further, the peritoneal adhesion may impede treatment of primary tumor, such as operation or chemotherapy, lead to a poor prognosis.
Objective: This study aims to treat malignant peritoneal adhesion with the combination of antiangiogenic agent and chemotherapy, evaluate the efficacy and safety of intraperitoneal antiangiogenic agent plus chemotherapy. As explosive endpoints, we will examination the expression of VEGF-A in peritoneal cavity during the treatment.
- Conditions
- Peritoneal Adhesion
- Being tested
- Bevacizumab, Carboplatin, paclitaxel
- Keywords
- bevacizumab, Intraperitoneal administration, Ovarian Cancer, Peritoneal Adhesion
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Bevacizumab 5mg/kg intraperitoneal administration every 3 weeks for 4-6 cycles
CarboplatinDrug
carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles
paclitaxelDrug
paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal bevacizumab+ carboplatin | Experimental | Intraperitoneal administration: intraperitoneal bevacizumab plus carboplatin every 3 weeks for 4-6 cycles
Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles Receives: Drug: Bevacizumab; Drug: Carboplatin; Drug: paclitaxel |
| Intraperitoneal carboplatin | Active comparator | Intraperitoneal administration: intraperitoneal carboplatin every 3 weeks
Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles Receives: Drug: Carboplatin; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal adhesion ORR (pORR)
Degree of adhesion was measured according to NAIR's criteria by laparoscopy. Grade 0 corresponded to no adhesions, Grade 1 and 2 corresponded to filmy adhesions and grade 3 and 4 to dense adhesions. No adhesions is defined as CR, dense adhesions change to filmy adhesions is defined as PR. The total efficiency ORR was calculated by taking the sum of CR+PR.
Measured: 3weeks after the last treatment
Secondary outcomes (5)
Number of Patients with Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: From first dose up to 1 month after the last treatment
Quality of Life (QoL)
Quality of Life (QoL) assessed by FACT-O
Measured: From first dose up to 1 year
Progression free survival (PFS)
From randomization until documented progressive disease or death
Measured: Up to 3 years
Overall survival (OS)
From randomization until death
Measured: Up to 3 years
Objective Response Rate (ORR)
The proportion of patients that have a best overall response of complete response (CR) or partial response (PR), as assessed by RECIST 1.1.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal AdhesionStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DuNan, Chinese PLA General Hospital
- Investigators
- Nan Du, PhD, Study director, PLA 304 hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095001
- Sponsor's protocol ID
- Intraperitoneal bev
- Status last verified
- Apr 2017
- First submitted
- 16 Mar 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PubMed 37185961
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese PLA Generation Hospital
- ClinicalTrials.gov ID
- NCT03095001
- Acronym / sponsor ID
- Intraperitoneal bev
- Conditions
- Peritoneal Adhesion
- Keywords
- bevacizumab, Intraperitoneal administration, Ovarian Cancer, Peritoneal Adhesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 29 Mar 2017 (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.
Background: Malignant peritoneal adhesion is a common complication and prognostic factor of ovarian cancer and other primary abdominal tumors. The incidence of peritoneal adhesion in advanced primary peritoneal tumor is 32-56%, which has increased by more than 10 times in the recent decade. Malignant peritoneal adhesion is closely associated with the morbidity and mortality of malignant intestinal obstruction. The peritoneal adhesion may aggravates the abdominal symptoms and reduce quality of life. Further, the peritoneal adhesion may impede treatment of primary tumor, such as operation or chemotherapy, lead to a poor prognosis.
Objective: This study aims to treat malignant peritoneal adhesion with the combination of antiangiogenic agent and chemotherapy, evaluate the efficacy and safety of intraperitoneal antiangiogenic agent plus chemotherapy. As explosive endpoints, we will examination the expression of VEGF-A in peritoneal cavity during the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal bevacizumab+ carboplatin | Experimental | Drug: Bevacizumab, Drug: Carboplatin, Drug: paclitaxelIntraperitoneal administration: intraperitoneal bevacizumab plus carboplatin every 3 weeks for 4-6 cycles Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles |
| Intraperitoneal carboplatin | Active comparator | Drug: Carboplatin, Drug: paclitaxelIntraperitoneal administration: intraperitoneal carboplatin every 3 weeks Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically and radiologically confirmed stage IV or postoperative recurrence ovarian cancer.
- Age of 18-70, Karnofsky score higher than 80.
- No severe functional damage of major organ, normal liver and kidney function.
- Peritoneal adhesion. (1) peritoneal adhesions diagnosed by microlaparoscopy or abdominal operations, and classification according to Nair criteria is performed. (1) must be met. (2) Peritoneal adhesion symptoms, intermittent abdominal pain, abdominal distension, nausea and vomiting, hard to pass stools or gas; (3) Peritoneal adhesion signs，abdominal distension, abdominal tenderness, reduced or absent bowel sounds; (4) B ultrasound or CT or MRI show peritoneal adhesion or adhesion-related complications.
Key exclusion criteria (6 listed)
- Complete intestinal obstruction and suitable for surgery.
- Patients known to be allergic to bevacizumab or any of the components of the drug.
- Other ongoing anti-tumor treatment.
- Heart disease with significant clinical symptoms, such as: congestive heart failure, coronary heart disease with symptom, arrhythmia hardly be controlled by drugs, myocardial infarction in 6 months, or heart failure
- Active wound infection and a history of uncontrolled psychiatric illness.
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 |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab 5mg/kg intraperitoneal administration every 3 weeks for 4-6 cycles | Drug | Intraperitoneal bevacizumab+ carboplatin |
| Carboplatincarboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles | Drug | Intraperitoneal bevacizumab+ carboplatin, Intraperitoneal carboplatin |
| paclitaxelpaclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles | Drug | Intraperitoneal bevacizumab+ carboplatin, Intraperitoneal carboplatin |
Primary outcome
Peritoneal adhesion ORR (pORR)
Time frame: 3weeks after the last treatment
Degree of adhesion was measured according to NAIR's criteria by laparoscopy. Grade 0 corresponded to no adhesions, Grade 1 and 2 corresponded to filmy adhesions and grade 3 and 4 to dense adhesions. No adhesions is defined as CR, dense adhesions change to filmy adhesions is defined as PR. The total efficiency ORR was calculated by taking the sum of CR+PR.
5 secondary outcomes
Number of Patients with Adverse Events
Time frame: From first dose up to 1 month after the last treatment
Quality of Life (QoL)
Time frame: From first dose up to 1 year
Progression free survival (PFS)
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 3 years
Objective Response Rate (ORR)
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Derived from this study: PubMed 37185961Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
- Individual participant dataSharing planned: Yes
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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.
Nan Du, PhD contact
Nan Du, PhD study director
PLA 304 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 Bevacizumab, Carboplatin and paclitaxel in people with Peritoneal Adhesion, run by Chinese PLA General 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 4 inclusion and 6 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 13 Apr 2017. 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 Nan Du, PhD (dunan304@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritoneal adhesion ORR (pORR) (time frame: 3weeks after the last treatment). 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 NCT03095001, which also lists 1 linked publication.
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 13 Apr 2017.