Sarcoma
Conditions
Keywords
Camrelizumab, Apatinib, UPS, ASPS
Brief summary
This study is a Single-arm, Open, Prospective, Single-center, Phase Ⅱ Clinical Study ,Target population is Advanced Inoperable Resection of Undifferentiated Pleomorphic Sarcoma (UPS) and Alveolar Soft Tissue Sarcoma (ASPS) . The purpose of this study was to evaluate the safety and efficacy of combination of Camrelizumab and Apatinib in the treatment of unresectable UPS and ASPS
Detailed description
In this study, eligible subject to accept study treatment. Camrelizumab combined with apatinib is a treatment cycle every 2 weeks
Interventions
Subject will receive SHR-1210 200mg every 2 weeks, with intravenous drip Apatinib 425 mg, oral, 5 consecutive days, 2 days off,each 14 day of a cycles
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects \>/= 16 years of age at the time of Informed Consent,male or female; 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 3. Life expectancy of at least three months; 4. Advanced undifferentiated pleomorphic sarcoma (UPS) confirmed by histopathology, patients who have failed in the first-line treatment and have progressed for 6 months; advanced acinar soft tissue sarcoma (ASPS) confirmed by histopathology, patients who have not been treated or who have failed in the first-line anti vascular drug treatment and progressed within 6 months; 5. Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard (the CT scan length of the tumor lesion \> 10 mm; 6. All acute toxic reactions caused by previous anti-tumor treatment were relieved to 0-1 level before enrollment (according to NCI CTCAE 5.03) Version) or to the level specified in the inclusion /
Exclusion criteria
(except for the toxicity that researchers think does not pose a safety risk to subjects, such as hair loss); if subjects undergo major surgery, they must have fully recovered from complications before starting treatment; 7. The main organ function is normal. All baseline laboratory requirements will be assessed and should be obtained within -14 days of randomization. Screening laboratory values must meet the following criteria. 1. Hemoglobin ≥ 8.0 g/dL (90 g/L) 2. Absolute neutrophil count ≥ 1.5× 109/L 3. Platelets ≥ 80× 109/L 4. Total bilirubin (TBIL) \< 1.5 × upper limit of normal (ULN) 5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 × upper limit of normal(ULN);but \< 5uln in patients with liver metastasis, alkaline phosphatase \< 5 × ULN 6. Serum creatinine ≤ 1× ULN or creatinine clearance \> 45 mL/minute (using Cockcroft/Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures or carried out pregnancy test (serum or urine) within 7 days before entering the group, and the result is negative, and they are willing to use appropriate contraceptive methods during the test and 60 days after the last administration of test drugs. For men, they must agree to use appropriate methods of contraception or have undergone surgical sterilization during the trial period and within 120 days after the last administration of the trial drug; 9. Subjects should be voluntarily participate in clinical studies and informed consent should be signed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free rate at 12 weeks (PFR 12weeks) | 12 weeks | The RECIST 1.1 standard was used to evaluate the disease progression and the 12 week progression free rate was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate(ORR) | 6.5 months | It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR |
| Progression free survival(PFS) | 6.5 months | Refers to the date from the beginning of treatment to the first occurrence of disease progression or death caused by any reason, whichever occurs first |
| Duration of Response（DOR) | 6.5 months | Time from the first assessment of Cr or PR to the first assessment of PD or death from any cause |
Contacts
Primary ContactYihebali Chi, doctor
Outcome results
None listed