Sarcoma
Conditions
Keywords
Sarcoma, SHR-1210, Apatinib
Brief summary
The main purpose of this study is to evaluate the efficacy of SHR-1210 plus Apatinib versus AMD plus IFO in participants with soft tissue sarcoma.
Interventions
DRUGSHR-1210 plus Apatinib
SHR-1210 200 mg q3w+ Apatinib 500 mg qd
DRUGADM plus IFO or IFO alone
ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w；if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects with the age from 16 years to 70 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;the ECOG performance status of 2 can be accepted after the amputation. * Life expectancy of at least 3 months. * Histologically confirmed diagnosis of advanced unresectable or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy.The histopathologic types as specified in the protocol. * Without prior systemic chemotherapy or relapse more than 6 months after the completion of last systemic chemotherapy. * Presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). * Acceptable liver function, renal function, hematologic status and coagulation function as specified in the protocol. * Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to randomization.Females of child-bearing potential and males must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of study drug. * Willingness to comply with the study protocol for any reason.
Exclusion criteria
* Receiving any previous anticancer treatment, other investigational drugs or any attenuated live vaccine with 4 weeks of the first does of study drug. * Prior treatment with PD-1/PD-L1/CTLA-4 targeted drugs or VEGFR targeted drugs. * Plan to receive surgery or radiotherapy to treat the sarcoma during the trail. * Radiological evidence of brain metastases or primary tumors. * Diagnosed other malignancies within the last 3 years from the first dose of drug. * Known allergy to any of the treatment components. * Active infection including human immunodeficiency virus (HIV) ,HBV or HCV. * Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks. | Randomization to Radiographic Progression or Death Due to Any Cause (Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | From date of randomization until the date of study completion, an average of 1 year, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks. | Baseline to documented disease Remission to study discontinuation, Partial Remission is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 30% decrease in the sum of the beaseline diameter of target lesions. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SHR-1210 Plus Apatinib SHR-1210 200 mg q3w+ Apatinib 500 mg qd | 50 |
| ADM Plus IFO or IFO Alone ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w；if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used. | 47 |
| Total | 97 |
Baseline characteristics
| Characteristic | ADM Plus IFO or IFO Alone | Total | SHR-1210 Plus Apatinib |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 90 Participants | 49 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 47 Participants | 97 Participants | 50 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 47 participants | 97 participants | 50 participants |
| Sex: Female, Male Female | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Male | 27 Participants | 57 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 50 | 2 / 47 |
| other Total, other adverse events | 50 / 50 | 45 / 47 |
| serious Total, serious adverse events | 27 / 50 | 13 / 47 |
Outcome results
Primary
Progression Free Survival (PFS)
Randomization to Radiographic Progression or Death Due to Any Cause (Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SHR-1210 Plus Apatinib | Progression Free Survival (PFS) | 5.6 months |
| ADM Plus IFO or IFO Alone | Progression Free Survival (PFS) | 5.5 months |
Secondary
Objective Response Rate (ORR)
Baseline to documented disease Remission to study discontinuation, Partial Remission is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 30% decrease in the sum of the beaseline diameter of target lesions.
Time frame: From date of randomization until the date of study completion, an average of 1 year, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SHR-1210 Plus Apatinib | Objective Response Rate (ORR) | 11 participants |
| ADM Plus IFO or IFO Alone | Objective Response Rate (ORR) | 5 participants |