Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Primary outcome:
Secondary outcome:
Duration of response(DOR), Disease control rate(DCR), Safety of the combination therapy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 inhibitor | Drug | Intravenous administration of SHR1210 (200mg/2weeks or 200mg/3weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response(DOR) | Evaluated by researchers based on the RECIST 1.1 standard | 2 years |
| Disease control rate(DCR) | Evaluated by researchers based on the RECIST 1.1 standard |
Not provided
Inclusion Criteria:
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).
All acute toxicity caused by previous antitumor treatments were alleviated to level 0-1 (according to NCI CTCAE version 4.03) or to the level specified by the enrollment/ exclusion criteria 1 day before the first dose except for subjects whose toxicity does not pose a safety risk);
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);
Non-surgical sterilization female patients;
Participants volunteered to participate in the study, signed informed consent, good compliance, and cooperated with the follow-up.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nong Yang | Contact | +8613055193557 | yangnong0217@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Nong Yang | Hunan Cancer Hospital | Principal Investigator |
| Kunyan Li | Hunan Cancer Hospital | Principal Investigator |
| Jing Wang |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Data can be shared no earlier than 1 year following the date of publication
please contact the principal investigator of this study or correspondence author of published work.
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| 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). |
|
| 2 years |
| Hunan Cancer Hospital |
| Principal Investigator |
| Gang Huang | Hunan Cancer Hospital | Principal Investigator |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| C000631724 | camrelizumab |
| C553458 | apatinib |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
Not provided
Not provided