- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
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Shandong
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Jinan, Shandong, Kina, 250117
- Rekruttering
- Shandong Cancer Hospital and Institute
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Ta kontakt med:
- Jinming Yu, PhD
- Telefonnummer: 13806406293
- E-post: sdyujinming@126.com
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Ta kontakt med:
- Xiangjiao Meng, PhD
- Telefonnummer: 13793150996
- E-post: mengxiangjiao@126.com
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Clinically significant toxicity
Tidsramme: First cycle (28 days)
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above grade 3 AEs
|
First cycle (28 days)
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6-month-PFS
Tidsramme: From the start of treatment to 6 months.
|
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 |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
OS
Tidsramme: opptil 2 år
|
OS er tidsintervallet fra behandlingsstart til død på grunn av en eller annen grunn eller tapt oppfølging
|
opptil 2 år
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PFS
Tidsramme: opptil 2 år
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Progresjonsfri-overlevelse
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opptil 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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: JINGMIN YU, PhD, Shandong Cancer Hospital and Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SHR-1210-RT-IIT-NSCLC-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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