Study of SHR-1210 Combined With Apatinib in the Treatment of Sarcoma

NCT04126993 | Unknown Phase 2 DMC

• 1 other identifier: E2019144
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To observe the effectiveness of SHR-1210 (Camrelizumab) combined with apatinib in the treatment of unresectable sarcoma patients with chemotherapy failure. The main observations were progression-free survival (PFS) and progression-free control rate (PFR), followed by objective response rate (ORR) (CR+PR), disease control rate (DCR) (CR+PR+SD), and overall survival (OS). To observe the safety of SHR-1210 (Camrelizumab) combined with apatinib in the treatment of sarcoma

Conditions

Sarcoma

Keywords

SHR-1210; Camrelizumab; Apatinib; Sarcoma; Jilong Yang

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.

  Within 2 years

Secondary Outcomes (3)

• Disease control rate (DCR）

  Within 2 years

• Objective tumor response rate (ORR)

  Within 2 years

• Overall survival(OS)

  Within 3 years

Study Arms (2)

Camrelizumab+ Apatinib test group

EXPERIMENTAL

Camrelizumab intravenous injection once every three weeks, Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.

Drug: Camrelizumab,; Drug: Apatinib

Apatinib single drug control group

ACTIVE COMPARATOR

Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.

Drug: Apatinib

Interventions

Camrelizumab, DRUG

Camrelizumab+ Apatinib test group: intravenous injection once every three weeks, Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.

Camrelizumab+ Apatinib test group

Apatinib DRUG

Apatinib single drug control group: Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.

Apatinib single drug control group; Camrelizumab+ Apatinib test group

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients voluntarily join the study, sign informed consent, and have good compliance；
• Pathologically confirmed patients with unresectable sarcoma (except GIST), clinical stage using the American Cancer Research Joint Committee (AJCC) TNM staging criteria. At least 1 double-path measurable lesion according to CT or MR I;
• At least one chemotherapy regimen (containing an anthracycline) was used to treat patients with disease progression or intolerance according to the solid tumor efficacy evaluation criteria (RECIST 1.1);
• Clear cell sarcoma, alveolar soft tissue sarcoma can be directly into the group without chemotherapy;
• \~75 years old, PS score: 0\~2; expected survival period is more than 3 months;

You may not qualify if:

• There are sufficient organ and bone marrow functions, defined as follows:
• Blood routine (no blood transfusion within 14 days before treatment, no use of G-CSF, no use of drugs to correct), Neutrophil count (ANC) ≥ 1,500/mm3 (1.5 × 109/L); Platelet count (PLT) ≥ 100,000/mm3 (100 × 109/L); Hemoglobin (Hb) ≥ 9 g/dL (90 g/L);
• Blood chemistry, Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (Cockroft-Gault formula) ≥ 60 ml / min; Total bilirubin (TBIL) ≤ 1.5 × ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 2.5 × ULN, liver metastases should be ≤ 5 × ULN;
• Coagulation, International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
• Urine routine, Urine protein \<2+; if urine protein ≥ 2+, 24-hour urine protein quantitation shows that the protein must be ≤ 1g;
• Thyroid function, Thyroid stimulating hormone (TSH) ≤ ULN; if abnormalities should be considered T3 and T4 levels, T3 and T4 levels can be selected;
• Female subjects of childbearing age must undergo a serum pregnancy test within 7 days prior to treatment and the results are negative, and are willing to use a medically recognized effective contraceptive measure during the study period and within 3 months after the last administration of the study drug (eg: Intrauterine devices, contraceptives or condoms; for male subjects whose partners are women of childbearing age, surgical sterilization is required, or an effective method of contraception is recommended during the study period and within 3 months after the last study administration;
• With my consent and signed informed consent, I am willing and able to follow planned visits, research treatments, laboratory tests and other testing procedures.
• The following treatments were received within 4 weeks of treatment:
• Radiotherapy, surgery, chemotherapy, immunization or molecular targeted therapy for tumors; Other clinical research drugs; Vaccination live attenuated vaccine;
• Previously received treatment with PD-1/PD-L1/CTLA-4 antibody or VEGFR single target/multi-target inhibitor;
• Surgery and/or radiation therapy for soft tissue sarcomas is planned during the study (regardless of \<5% of the bone marrow area);
• Imaging diagnosis of central nervous system tumors;
• Immune-suppressing drugs have been used within 14 days prior to initiation of treatment, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (That is, no more than 10 mg / day of prednisolone or equivalent physiological dose of other corticosteroids);
• There is any active autoimmune disease or a history of autoimmune disease (Including but not limited to: Autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or asthma that have been completely relieved in childhood and currently do not require medical intervention may be included, or a history of allogeneic organ transplantation or a history of allogeneic hematopoietic stem cell transplantation);

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Hospital & Institute

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jilong Yang, M.D., Ph.D

CONTACT

+8618622221626; yangjilong@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 15, 2019
• Study Start: June 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: October 15, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)