- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03557411
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Hypofraction Radiotherapy in Patients With NSCLC
A Phase II Clinical Trial of SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined With Hypofraction Radiotherapy in Patients With Previously Treated Oligometastatic NSCLC
This is a phase II clinical trial of SHR-1210 (an anti-PD-1 Inhibitor) simultaneously combined with hypofraction radiotherapy in patients with previously treated oligometastatic NSCLC.
It is a single center, single arm, open label trial. Subjects with oligometastatic non-small-cell lung cancer who is previously treated will be recruited. 12 subjects will be enrolled at the first part of the study which aims to evaluate the tolerability of SHR-1210 in combination with hypofraction radiotherapy. 30 subjects will be enrolled at the second part of the study which aims to evaluate the primary efficacy and safety of SHR-1210 in combination with hypofraction radiotherapy.
Studieoversigt
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Shandong
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Jinan, Shandong, Kina, 250117
- Rekruttering
- Shandong Cancer Hospital and Institute
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Kontakt:
- Jinming Yu, PhD
- Telefonnummer: 13806406293
- E-mail: sdyujinming@126.com
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Kontakt:
- Xiangjiao Meng, PhD
- Telefonnummer: 13793150996
- E-mail: mengxiangjiao@126.com
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Subjects will voluntarily participate in this study and sign informed consent.
- NSCLC subject with 1 to 5 distant metastatic lesions in stage IV.
- No clear driven genes (including but not limited to EGFR, ALK).
- Previously received more than 1 chemotherapy regimen and progressed/recurred.
- At least one lesion is suitable for hypofraction radiotherapy.
- There is at least one measurable lesion.
- 18 to 75 years old
- ECOG 0-1
- The function of vital organs meets the following requirements. ANC≥1.5×10^9/L, PLT≥100×10^9/L, Hb≥9g/dL, ALB≥3g/dL, TSH ≤ULN, Bilirubin ≤ 1 times ULN; ALT and AST ≤1.5 times ULN. AKP ≤ 2.5 times ULN. CREA ≤1.5 times ULN or CCr≥60mL/min。
- The estimated survival period is more than 3 months.
- Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.
Exclusion Criteria:
- The subjects had any history of autoimmune disease or active autoimmune disease.
- Subjects are using immunosuppressive agents, or systemic, or absorptive, local hormone therapy to achieve immunosuppression.It is still in use within 2 weeks of the entry.
- Subjects with severe allergic reactions to other monoclonal antibodies.
- The subjects had a central nervous system metastases of clinical symptoms.
- Central squamous cell lung carcinoma.
- Imaging (CT or MRI) shows that tumors invade large blood vessels or are indistinct with blood vessels.
- Imaging (CT or MRI) showed significant pulmonary vacuity or necrotic tumors,Borderline adenocarcinoma accompanied by a cavity can be considered after discussion with investigator.
- Failing to properly control the clinical symptoms or disease of the heart.
- Subjects had active infections.
- Subjects may receive other systemic antitumor therapy during the study period.
- Other clinical trials of drugs were used in the first four weeks of the first medication.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: SHR-1210 +Hypofraction radiotherapy
SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy
|
SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Clinically significant toxicity
Tidsramme: First cycle (28 days)
|
above grade 3 AEs
|
First cycle (28 days)
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6-month-PFS
Tidsramme: From the start of treatment to 6 months.
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6-month-progression free survival rate
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From the start of treatment to 6 months.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
OS
Tidsramme: op til 2 år
|
OS er tidsintervallet fra behandlingsstart til død på grund af en hvilken som helst årsag eller tab af opfølgning
|
op til 2 år
|
PFS
Tidsramme: op til 2 år
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Progressionsfri-overlevelse
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op til 2 år
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AEs+SAEs
Tidsramme: from the first drug administration to within 30 days for the last SHR-1210 dose
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Adverse Events and Serious Adverse Events
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from the first drug administration to within 30 days for the last SHR-1210 dose
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ORR
Tidsramme: At baseline,at the time point of every 8 weeks
|
Objective Response Rate
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At baseline,at the time point of every 8 weeks
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DCR
Tidsramme: at the time point of every 8 weeks
|
Disease Control Rate
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at the time point of every 8 weeks
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: JINGMIN YU, PhD, Shandong Cancer Hospital and Institute
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SHR-1210-RT-IIT-NSCLC-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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