OsteosarcomaPhase 2MAPACNCT04351308
Comparison of MAPI+Camrelizumab Versus API+Apatinib Versus MAPI in Patients With a Poor Response to Preoperative Chemotherapy for Newly Diagnosed High-grade Osteosarcoma
A Phase 2 study testing MAPI chemotherapy, Apatinib Mesylate and Camrelizumab in people with Osteosarcoma and Survival, run by Peking University People's Hospital at 1 site in China.
Trial summary
Treatment strategies for high-grade osteosarcoma with multidrug chemotherapy and resection result in 3-year event-free survival of 60-70%. The most common factors predicting survival are presence of metastases, histological response to preoperative chemotherapy and complete surgical resection. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Osteosarcoma, Survival, Chemotherapy Effect
- What is being tested?
- MAPI chemotherapy, Apatinib Mesylate and Camrelizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 31 Dec 2022
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed high-grade osteosarcoma, including second malignancies
- Tumor (primary, metastatic, or both) resectable OR is expected to become resectable after neoadjuvant induction chemotherapy
- Suitable for neoadjuvant chemotherapy and adjuvant chemotherapy
- Performance status - Lansky 50-100% (for patients under 16 years of age); Performance status - WHO or ECOG 0-2 with a life expectancy >3 months
- normal cardiac function (shortening fraction >28%), normal hearing, normal bone marrow as shown by an absolute neutrophil count of at least 1·5 × 10⁹ cells per L (or a white blood cell count of at least 3 × 10⁹ cells per L if neutrophil count is not available), and a platelet count of at least 100 000 platelets per μL
- Patients were also required to have a serum bilirubin concentration of at most less than 1·5 times the upper limit of normal and a normal creatinine concentration for their age as per protocol
- Women of child-bearing potential had to take adequate contraceptive measures and have a negative pregnancy test within 7 days of study entry.
Who cannot join
- patients who have recieved anti-angiogenic TKIs or anti-PD-1/PD-L1 antibodies
- allergy to chemotherapy or apatinib or camrelizumab
- other severe illness (eg, psychosis or previous history of cardiovascular disease)
- symptomatic or known CNS metastases
- previous or concurrent second primary malignant tumours
- had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++, and so on
- had other infections or wounds
- pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
Lu Xie, M.D., +8613401044719, xie.lu@hotmail.com
Xin Sun, M.D., +8613810548607, xinsun1981@hotmail.com
About this study
Official title: A Randomized Trial of Comparison of MAPI+Camrelizumbab Verus API+Apatinib Versus MAPI in Patients With a Poor Response to Preoperative Chemotherapy for Newly Diagnosed High-grade Osteosarcomaies : an Open-label, Exploratory Study
Treatment strategies for high-grade osteosarcoma with multidrug chemotherapy and resection result in 3-year event-free survival of 60-70%. The most common factors predicting survival are presence of metastases, histological response to preoperative chemotherapy and complete surgical resection. Four of the active drugs in osteosarcoma include cisplatin, doxorubicin, high-dose methotrexate and ifosfamide and this combination (MAPI), given preoperatively and postoperatively, is widely used for the treatment of osteosarcoma in China. Apatinib also has activity in advanced setting and when incorporated into the treatment of patients with metastatic disease seemed to improve progression-free survival. Combination of apatinib and camrelizumab resulted in durable therapuetic effect in selected cases. Though EURAMOUS-1 suggested that changing chemotherapy postoperatively on the basis of histological response did not improve outcomes. The exploratory study with radomised design to compare combination of chemotherapy with target drug or combination of chemotherapy with anti-PD-1 antibody versus standard chemotherapy has not been tried yet. Thus we aim to investigate the efficacy and toxicity of these combiantions versus standard chemotherapy in this study.
- Conditions
- Osteosarcoma, Survival, Chemotherapy Effect, Toxicity, Drug
- Being tested
- MAPI chemotherapy, Apatinib Mesylate, Camrelizumab
- Keywords
- osteosarcoma, doxirubicin, cisplatin, methotrexate, ifosfamide, apatinib, camrelizumab
- Medical subject headings
- Osteosarcoma, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAPI chemotherapyDrug
AP = Doxorubicin (Adriamycin) 37.5 mg/m2/day * 2day (total/cycle 75 mg/m²)
+ Cisplatin 120 mg/m2/course (total/cycle 120 mg/m²) ; M = Methotrexate 12000 mg/m2 (total/cycle 12000 mg/m²) with leucovorin rescue; I = Ifosfamide 2400 mg/m2/day *5day (total/cycle 12000 mg/m²)
Apatinib MesylateDrug
anti-angiogenesis tyrosine kinase inhibitors 500 mg orally daily
CamrelizumabDrug
anti-PD-1 antibody 200mg ivgtt. Q2W
| Study group | Role | What they receive |
|---|---|---|
| API+apatinib | Experimental | AP = Doxorubicin (Adriamycin) 20 mg/m2/day * 2 day (total/cycle 40 mg/m²)
+ Cisplatin 100 mg/m2/course (total/cycle 120 mg/m²);
I = Ifosfamide 2000 mg/m2/day *5 day (total/cycle 10000 mg/m²);
apatinib = 500 mg QD; Receives: Drug: MAPI chemotherapy; Drug: Apatinib Mesylate |
| MAPI+camrelizumab | Experimental | AP = Doxorubicin (Adriamycin) 37.5 mg/m2/day * 2day (total/cycle 75 mg/m²)
+ Cisplatin 120 mg/m2/course (total/cycle 120 mg/m²);
M = Methotrexate 12000 mg/m2 (total/cycle 12000 mg/m²) with leucovorin rescue;
I = Ifosfamide 2400 mg/m2/day *5day (total/cycle 12000 mg/m²);
camralizumab = 200mg ivgtt. Q2W; Receives: Drug: MAPI chemotherapy; Drug: Camrelizumab |
| MAPI | Active comparator | AP = Doxorubicin (Adriamycin) 37.5 mg/m2/day * 2day (total/cycle 75 mg/m²)
+ Cisplatin 120 mg/m2/course (total/cycle 120 mg/m²);
M = Methotrexate 12000 mg/m2 (total/cycle 12000 mg/m²) with leucovorin rescue;
I = Ifosfamide 2400 mg/m2/day *5day (total/cycle 12000 mg/m²); Receives: Drug: MAPI chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
event-free survival rate
from initial treatment after definitive surgery to progression/death/ last follow up
Measured: 2 years
Secondary outcomes (1)
overall survival rate
from initial treatment after definitive surgery to death/ last follow up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 May 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Sarcoma Study Group
- Responsible party
- Sponsor
- Investigators
- Wei Guo, M.D., Principal investigator, Musculoskeletal Tumor Center of Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351308
- Sponsor's protocol ID
- PKUPH-sarcoma 09
- Acronym
- MAPAC
- Status last verified
- May 2020
- First submitted
- 15 Apr 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Comparison of MAPI+Camrelizumbab Verus API+Apatinib Versus MAPI in Patients With a Poor Response to Preoperative Chemotherapy for Newly Diagnosed High-grade Osteosarcomaies : an Open-label, Exploratory Study
- ClinicalTrials.gov ID
- NCT04351308
- Acronym / sponsor ID
- MAPAC / PKUPH-sarcoma 09
- Conditions
- Osteosarcoma, Survival, Chemotherapy Effect, Toxicity, Drug
- Keywords
- osteosarcoma, doxirubicin, cisplatin, methotrexate, ifosfamide, apatinib, camrelizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Chinese Sarcoma Study Group
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Apr 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.
Treatment strategies for high-grade osteosarcoma with multidrug chemotherapy and resection result in 3-year event-free survival of 60-70%. The most common factors predicting survival are presence of metastases, histological response to preoperative chemotherapy and complete surgical resection. Four of the active drugs in osteosarcoma include cisplatin, doxorubicin, high-dose methotrexate and ifosfamide and this combination (MAPI), given preoperatively and postoperatively, is widely used for the treatment of osteosarcoma in China. Apatinib also has activity in advanced setting and when incorporated into the treatment of patients with metastatic disease seemed to improve progression-free survival. Combination of apatinib and camrelizumab resulted in durable therapuetic effect in selected cases. Though EURAMOUS-1 suggested that changing chemotherapy postoperatively on the basis of histological response did not improve outcomes. The exploratory study with radomised design to compare combination of chemotherapy with target drug or combination of chemotherapy with anti-PD-1 antibody versus standard chemotherapy has not been tried yet. Thus we aim to investigate the efficacy and toxicity of these combiantions versus standard chemotherapy in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| API+apatinib | Experimental | Drug: MAPI chemotherapy, Drug: Apatinib MesylateAP = Doxorubicin (Adriamycin) 20 mg/m2/day * 2 day (total/cycle 40 mg/m²) + Cisplatin 100 mg/m2/course (total/cycle 120 mg/m²); I = Ifosfamide 2000 mg/m2/day *5 day (total/cycle 10000 mg/m²); apatinib = 500 mg QD; |
| MAPI+camrelizumab | Experimental | Drug: MAPI chemotherapy, Drug: CamrelizumabAP = Doxorubicin (Adriamycin) 37.5 mg/m2/day * 2day (total/cycle 75 mg/m²) + Cisplatin 120 mg/m2/course (total/cycle 120 mg/m²); M = Methotrexate 12000 mg/m2 (total/cycle 12000 mg/m²) with leucovorin rescue; I = Ifosfamide 2400 mg/m2/day *5day (total/cycle 12000 mg/m²); camralizumab = 200mg ivgtt. Q2W; |
| MAPI | Active comparator | Drug: MAPI chemotherapyAP = Doxorubicin (Adriamycin) 37.5 mg/m2/day * 2day (total/cycle 75 mg/m²) + Cisplatin 120 mg/m2/course (total/cycle 120 mg/m²); M = Methotrexate 12000 mg/m2 (total/cycle 12000 mg/m²) with leucovorin rescue; I = Ifosfamide 2400 mg/m2/day *5day (total/cycle 12000 mg/m²); |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed high-grade osteosarcoma, including second malignancies
- Tumor (primary, metastatic, or both) resectable OR is expected to become resectable after neoadjuvant induction chemotherapy
- Suitable for neoadjuvant chemotherapy and adjuvant chemotherapy
- Performance status - Lansky 50-100% (for patients under 16 years of age); Performance status - WHO or ECOG 0-2 with a life expectancy >3 months
- normal cardiac function (shortening fraction >28%), normal hearing, normal bone marrow as shown by an absolute neutrophil count of at least 1·5 × 10⁹ cells per L (or a white blood cell count of at least 3 × 10⁹ cells per L if neutrophil count is not available), and a platelet count of at least 100 000 platelets per μL
Key exclusion criteria (8 listed)
- patients who have recieved anti-angiogenic TKIs or anti-PD-1/PD-L1 antibodies
- allergy to chemotherapy or apatinib or camrelizumab
- other severe illness (eg, psychosis or previous history of cardiovascular disease)
- symptomatic or known CNS metastases
- previous or concurrent second primary malignant tumours
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 |
|---|---|---|
| MAPI chemotherapyAP = Doxorubicin (Adriamycin) 37.5 mg/m2/day * 2day (total/cycle 75 mg/m²) + Cisplatin 120 mg/m2/course (total/cycle 120 mg/m²) ; M = Methotrexate 12000 mg/m2 (total/cycle 12000 mg/m²) with leucovorin rescue; I = Ifosfamide 2400 mg/m2/day *5day (total/cycle 12000 mg/m²) | Drug | API+apatinib, MAPI, MAPI+camrelizumab |
| Apatinib Mesylateanti-angiogenesis tyrosine kinase inhibitors 500 mg orally daily | Drug | API+apatinib |
| Camrelizumabanti-PD-1 antibody 200mg ivgtt. Q2W | Drug | MAPI+camrelizumab |
Primary outcome
event-free survival rate
Time frame: 2 years
from initial treatment after definitive surgery to progression/death/ last follow up
1 secondary outcome
overall survival rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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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.
Wei Guo, M.D. principal investigator
Musculoskeletal Tumor Center of Peking University People's 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 MAPI chemotherapy, Apatinib Mesylate and Camrelizumab in people with Osteosarcoma and Survival, run by Peking University People's 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 7 inclusion and 8 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 19 May 2020. 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 Lu Xie, M.D. (+8613401044719, xie.lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
event-free survival rate (time frame: 2 years). 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 19 May 2020.