Soft Tissue Sarcoma
Conditions
Keywords
Albumin-bound paclitaxel, Camrelizumab, PD-1, Sarcoma
Brief summary
In this open, single center, one- armed clinical study, enrolled patients will receive the following treatment: 300 mg/m2 of nab-paclitaxel (Hengrui Pharmaceutical, Lianyungang, China) and 200 mg of PD-1 inhibitor (camrelizumab; Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events. The primary end point was progression-free survival at 4 months. Secondary objectives were objective response rate and safety.
Detailed description
There is increasing evidence that combination therapy with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and programmed cell death protein 1 (PD-1) inhibitor is safe and efficacious in treating many types of malignant tumors. However, clinical data demonstrating the effect of this treatment combination for patients with metastatic soft tissue sarcoma are currently limited. In this open, single center, one- armed clinical study, enrolled patients will receive the following treatment: 300 mg/m2 of nab-paclitaxel (Hengrui Pharmaceutical, Lianyungang, China) and 200 mg of PD-1 inhibitor (camrelizumab; Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events. The primary end point was progression-free survival at 4 months. Secondary objectives were objective response rate and safety.
Interventions
DRUGCamrelizumab
Enrolled patients will receive the following treatment: 200 mg of PD-1 inhibitor (camrelizumab; Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events.
DRUGAlbumin-Bound Paclitaxel
Enrolled patients will receive 300 mg/m2 of nab-paclitaxel (Hengrui Pharmaceutical, Lianyungang, China) via a 30-min intravenous infusion on day 1. The treatment was repeated every three weeks until progressive disease occurrence or unacceptable adverse events.
Sponsors
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Ages 16-70, male and female. 2. ECOG score of physical condition was 0-1. This can be extended to 2 points for amputees. 3. Expected survival ≥3 months. 4. Subjects with distant metastases or locally advanced soft tissue sarcomas determined by the investigator to be unsuitable for surgical treatment (pathologic subtypes include undifferentiated pleomorphic sarcomas, synovial sarcomas, leiomyosarcomas, hemangiosarcomas, clear cell sarcomas, epithelioid sarcomas, fibrosarcomas, and undifferentiated/poorly differentiated liposarcomas). 5. Subjects with metastatic/surgically unresectable soft tissue sarcoma who received prior systemic treatment or who had a sensitive recurrence (a recurrence more than 6 months after the last chemotherapy) after chemotherapy. 6. Measurable lesions in compliance with RECIST1.1 criteria. 7. All acute toxicities resulting from prior antitumor therapy or surgery were alleviated by the first day of the first cycle (C1D1) to level 0-1 (according to NCI-CTCAE 4.03) or to the level specified in the inclusion/
Exclusion criteria
(except for toxicities such as hair loss that the investigator did not consider to pose a safety risk to the subject). 8. Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment)as determined by: Hemoglobin ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L (for patients with advanced hepatocellular carcinoma), Platelet count ≥ 100×109/L (for patients with advanced gastric cancer); serum albumin ≥2.8 g/dL; serum total bilirubin (TBIL)≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal(ULN), for subjects with liver metastases, ALT and AST≤5×ULN; Calculated creatinine clearance (CrCl) \> 50 mL/min (Cockcroft-Gault formula will be used to calculate CrCl). 9. Urine routine: urine protein \<2+; If urine protein ≥2+, 24-hour urine protein quantification must be ≤1g; Thyroid function: Thyroid stimulating hormone (TSH)≤ULN; If FT3(T3) and FT4(T4) levels are abnormal, FT3(T3) and FT4(T4) levels can be selected if they are normal. 10. Female subjects of reproductive age must have performed a serum pregnancy test negative within 7 days prior to medication and be willing to use a medically approved highly effective contraceptive method (e.g., an intrauterine device, birth control pill, or condom) during the study period and for 3 months after the last medication; Male subjects with a female partner of reproductive age were surgically sterilized or agreed to use an effective method of contraception during the study period and for 3 months after the last study administration. 11. With my consent and informed consent, I am willing and able to comply with the planned visit, research treatment, laboratory examination and other experimental procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Up to approximately 24months | Progression-free survival is defined as time from enrollment to the first occurrence of progression of disease or death from any cause within 63 days of last response assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | Up to approximately 24months | Defined as the proportion of patients who achieve partial response or complete response according to RECIST 1.1. |
Countries
China
Contacts
Primary ContactJiaqiang Wang, Dr.
Outcome results
None listed