Clinical Study of PD-1 Monoclonal Antibody SHR-1210 and Apatinib in Advanced NSCLC, Soft Tissue Sarcoma, and Uterine Cancer

NCT04239443 | Unknown Phase 2

• 1 other identifier: HNCHIIT001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In this one-arm study, histologically or cytologically confirmed advanced NSCLC, uterine malignancies, and soft tissue sarcoma will be enrolled to investigate the efficacy and safety of PD-1 monoclonal antibody SHR-1210 and apatinib, at the same time, peripheral circulating blood tumor cells (CTC) detection and CTC-based PD-L1 antibody immunofluorescence detection will be performed.

Conditions

Advanced Non Small Cell Lung Cancer; Uterine Cancer; Soft Tissue Sarcoma

Keywords

immunotherapy; PD-1 checkpoint inhibitor; circulating blood tumor cells (CTC)

Outcome Measures

Primary Outcomes (5)

• Objective remission rate (ORR)

  Evaluated by researchers based on the RECIST 1.1 standard

  2 years

• Progression free survival (PFS)

  Evaluated by researchers based on the RECIST 1.1 standard

  2 years

• Overall survival (OS)

  Evaluated by researchers based on the RECIST 1.1 standard

  2 years

• The number of Circulating Tumor Cell (CTC)

  2 years

• Analysis of PD-L1 expression on Circulating Tumor Cell (CTC) and tumor tissue

  2 years

Secondary Outcomes (2)

• Duration of response(DOR)

  2 years

• Disease control rate(DCR)

  2 years

Study Arms (1)

SHR1210 and Apatinib

EXPERIMENTAL

NSCLC participants will be given intravenous administration of SHR-1210 (200mg/2w) and oral of Apatinib (250mg/d) , soft tissue sarcoma will be given intravenous administration of SHR-1210 (200mg/3w) and oral of Apatinib (500mg/d), and uterine cancer will be given intravenous administration of SHR-1210 (200mg/3w) and oral of Apatinib (250mg/d). The duration of treatment will till the disease progression, death, or unacceptable toxicity show up.

Drug: PD-1 inhibitor; Drug: Apatinib

Interventions

PD-1 inhibitor DRUG

Intravenous administration of SHR1210 (200mg/2weeks or 200mg/3weeks)

Also known as: Camrelizumab

SHR1210 and Apatinib

Apatinib DRUG

NSCLC and Uterine cancer will be given oral of Apatinib (250mg/d), soft tissue sarcoma will be given oral of Apatinib (500mg/d).

SHR1210 and Apatinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years, both men and women (Uterine cancer limited to women);
• NSCLC: Pathologically confirmed advanced (IIIB, stage IV) NSCLC with at least 1 measurable lesion that meets the RECIST v1.1 standard without local treatment, of which stage IIIb patients are incapable, unsuitable for surgery or radical radiotherapy, NSCLC patients have failed at least the first-line standard treatment or refused to receive standard treatment, or chemotherapy intolerance, Among them, patients with sensitive gene mutations must fail after TKI treatment (patients who have failed first-line or second-line treatment may participate in this study), Patients with EGFR and ALK mutations must undergo EGFR and ALK inhibitor treatment failure and EGFR T790M mutation negative, for EGFR T790M-positive patients, third-generation EGFR TKI treatment fails.
• Soft tissue sarcoma: Patients with distant metastasis or locally advanced disease who have previously failed chemotherapy or sensitive recurrence or metastasis to soft tissue sarcoma. Subjects who have judged by the investigator to be unsuitable for surgical treatment (including amputation) of soft tissue sarcomas (diagnosed pathologically or cytologically, but excluding gastrointestinal stromal tumors, chondrocyte-bone tumors, embryonic/acinar rhabdomyosarcoma, Juventus Sarcoma, extensive distant metastatic soft tissue tumors such as keloid cutaneous fibrosarcoma and inflammatory myofibroblastic sarcoma, malignant peripheral nerve sheath tumor, keloid cutaneous fibrosarcoma, inflammatory myofibroblastic sarcoma, malignant interstitial Dermatoma) (priority consideration: synovial sarcoma, undifferentiated multiline sarcoma, dedifferentiated liposarcoma), and measurable lesions that meet the RECIST 1.1 standard.
• Uterine cancer: Pathologically confirmed uterine cancer, including cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma), endometrial cancer, and uterine sarcoma, at least one measurable lesion that meets RECIST 1.1 criteria, recurrence/Persons with persistent cervical cancer, endometrial cancer, and uterine sarcoma cannot be cured by surgery and/or radiotherapy, have received at least a first-line treatment for advanced (stage IVB), recurrent/persistent cervical cancer, endometrial cancer, uterine sarcoma Systemic chemotherapy patients (qualified to participate in this study after the progress of first-line chemotherapy).

You may not qualify if:

• Able to provide tumor samples (at least 20 unstained tumor samples or fresh tissue specimens embedded in formalin-fixed paraffin within six months, 4ml of peripheral blood samples before treatment and each effect evaluation);
• ECOG score: 0-1, patients with soft tissue sarcoma amputation can be relaxed to 2 points;
• Expected survival ≥ 12 weeks;
• The function of important organs meets the following requirements (excluding the use of any blood components and cell growth factors during screening);
• Absolute neutrophil count ≥1.5 × 109 / L;
• platelets ≥100 × 109/L;
• Hemoglobin ≥9g/dL;
• serum albumin ≥3g/dL;
• total bilirubin ≤ 1.5ULN;
• ALT and AST ≤1.5ULN;
• AKP ≤ 2.5ULN;
• Serum creatinine ≤ 1.5ULN or creatinine clearance ≥ 60mL/min;
• Non-surgical sterilization female patients;
• Participants volunteered to participate in the study, signed informed consent, good compliance, and cooperated with the follow-up.
• Participants who had any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis , Hyperthyroidism, decreased thyroid function; subjects with vitiligo or childhood asthma has completely resolved, adults can be included without any intervention; subjects with bronchodilators for medical intervention can not be included in asthma;

Sponsors & Collaborators

• Hunan Cancer Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Hunan cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Uterine Neoplasms; Sarcoma

Interventions

Immune Checkpoint Inhibitors; camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Nong Yang

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Kunyan Li

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Jing Wang

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Gang Huang

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nong Yang

CONTACT

+8613055193557; yangnong0217@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients fulfilling Eligibility Criteria will be included in our study. NSCLC participants will be given intravenous administration of SHR-1210 (200mg/2w) and oral of Apatinib (250mg/d) , soft tissue sarcoma will be given intravenous administration of SHR-1210 (200mg/3w) and oral of Apatinib (500mg/d), and uterine cancer will be given intravenous administration of SHR-1210 (200mg/3w) and oral of Apatinib (250mg/d). Treatments will be administrated until disease progression, death, or unacceptable toxicity.

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 27, 2020
• Study Start: January 30, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: please contact the principal investigator of this study or correspondence author of published work.

Locations

CN (1)