A Study of Carilizumab in Combination With Apatinib in Subjects With Unresectable UPS and ASPS

NCT04447274 | Unknown Phase 2

• 1 other identifier: UPS and ASPS-IIT-SHR1210
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

Sarcoma

Keywords

Camrelizumab; Apatinib; UPS; ASPS

Outcome Measures

Primary Outcomes (1)

• Progression-free rate at 12 weeks (PFR 12weeks)

  The RECIST 1.1 standard was used to evaluate the disease progression and the 12 week progression free rate was calculated.

  12 weeks

Secondary Outcomes (3)

• Objective Response Rate(ORR)

  6.5 months

• Progression free survival(PFS)

  6.5 months

• Duration of Response（DOR)

  6.5 months

Study Arms (1)

Camrelizumab and Apatinib

EXPERIMENTAL

Drugs should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Drug: Camrelizumab and Apatinib

Interventions

Camrelizumab and Apatinib DRUG

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

Camrelizumab and Apatinib

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects \>/= 16 years of age at the time of Informed Consent,male or female;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
• Life expectancy of at least three months;
• 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;
• Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard (the CT scan length of the tumor lesion \> 10 mm;

You may not qualify if:

• 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.
• Hemoglobin ≥ 8.0 g/dL (90 g/L)
• Absolute neutrophil count ≥ 1.5× 109/L
• Platelets ≥ 80× 109/L
• Total bilirubin (TBIL) \< 1.5 × upper limit of normal (ULN)
• 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
• Serum creatinine ≤ 1× ULN or creatinine clearance \> 45 mL/minute (using Cockcroft/Gault formula);
• 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;
• Subjects should be voluntarily participate in clinical studies and informed consent should be signed.
• Known active central nervous system (CNS) metastasis and / or cancerous meningitis. Subjects who had previously received brain metastases may participate as long as they are stable and meet the following criteria: there is no evidence of imaging progress for at least four weeks prior to the first dose of trial treatment, and any neurological symptoms have returned to baseline, there is no evidence of new or expanded brain metastases, and steroids are not used for at least seven days prior to the trial treatment. This exception does not include cancerous meningitis, regardless of its clinical stability;

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Sarcoma

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Yihebali Chi, doctor

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihebali Chi, doctor

CONTACT

13911075626; yihebalichi6@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 25, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 25, 2020

Record last verified: 2020-06