- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02403544
Phase I Study of Image-Guided Radiation Concurrent With Double-Agent Chemotherapy for Hepatocellular Carcinoma
4. januar 2016 oppdatert av: Jing Jin, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Image-Guided Radiation Therapy (IGRT) Associated With Concurrent Capecitabine and Oxaliplatin in the Treatment of Locally Advanced or Inoperable Hepatocellular Carcinoma (HCC): A Phase I Study
This is a phase I study to evaluate the safety of concurrent chemoradiation combining radiotherapy (IGRT) with two cytotoxic agents, capecitabine and oxaliplatin in patients with advanced or inoperable hepatocellular carcinoma.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
In this phase I study, patients with advanced or inoperable hepatocellular carcinoma, or those failed other strategies will be recruited.
The primary tumor and nearby metastatic nodes will be irradiated with Image-Guided Radiation Therapy (IGRT) mostly with conventional fractions.
During the course, oral capecitabine and intravenous oxaliplatin will be given concurrently.
The maximum tolerated dose (MTD) for the two drugs will be determined during escalation according to the occurrence of dose limiting toxicities (DLT).
Studietype
Intervensjonell
Registrering (Forventet)
30
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jing Jin, doctor
- Telefonnummer: 86-10-87787456
- E-post: Jingjin1025@163.com
Studer Kontakt Backup
- Navn: Hao Jing, doctor
- Telefonnummer: 86-10-87788122
- E-post: owletskim@163.com
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100021
- Rekruttering
- Cancer Hospital, Chinese Academy of Medical Sciences
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Criteria:
Inclusion Criteria:
- KPS≥80.
- Life expectancy≥16 months.
- Histopathologically or clinically diagnosed HCC.
- Barcelona-Clinic Liver Cancer (BCLC) 0-C without distant metastasis.
- The primary tumor is unresectable, inoperable or failed in other previous therapies.
- Child-pugh≤6 (Child A), Indocyanine green retention rate at 15min <20%.
- HGb≥100g/L, WBC≥3×109/L, NEUT≥1.5×109/L, PLT≥75×109/L, Creatine≤1.5mg/dl (UNL), Bun≤30mg/dl, Alanine aminotransferase/Aspartate aminotransferase/Alkaline phosphatase≤2.5×UNL, TBil≤1.5×UNL, Prothrombin time≤1.5×UNL, INR≤1.5.
- No prior liver or upper abdomen radiation therapy.
- No previous history of allergic reaction attributed to fluorouracil or platinum drugs.
- Be conscious and could cooperate and comply with protocols for the study, such as simulation, smooth breathing and positioning for radiotherapy.
- Be ready to be followed up.
- Fulfill dosages requirement for targets and dose limits for organs at risk.
- The patient should be under anti-hepatitis-virus therapy if indicated.
- Sorafenib should be discontinued 7 days before the start of irradiation.
- Subjects informed of the diagnosis of advanced HCC who are fully informed about the content of the study by the investigator using the written consent form, and give written consent to participate in the study of their own free will.
Exclusion Criteria:
- KPS≤70.
- Existing distant metastasis.
- Child-Pugh≥7, Indocyanine green retention rate at 15min ≥20%.
- Primary tumor within the liver is not to be irradiated.
- Past liver transplantation.
- Complications of cirrhosis: active gastrointestinal bleeding, hepatic encephalopathy, refractory ascites, peritonitis, hepatorenal syndrome, hepatopulmonary syndrome.
- Upper gastrointestinal bleeding within 3 months.
- Any other carcinomas, except cured non-melanoma skin carcinoma, treated in-situ cervical cancer and ≤T1 bladder cancer.
- After planning optimization, the physician still consider risky to treat the patient with the plan or the benefit is negligible.
- Not conscious or can not cooperate or comply with the protocol for the study.
- Previous history of allergic reaction attributed to fluorouracil or platinum.
- Patients with serious comorbidities or uncontrolled medical conditions that the investigator feels might compromise study participation (including but not limited to: myocardial infarction, congestive heart failure (NYHA>2), unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, uncontrolled psychotic disorders, uncontrolled hypertension and cerebrovascular disease with previous stroke within 6 months, serious infections,positive HIV test, poorly controlled diabetes mellitus with fasting blood-glucose >8mmol/L or 2-hour postprandial blood glucose >11mmol/L within the past month).
- Thrombolytic therapy within 4 weeks, or any concurrent anti-coagulant therapy.
- Pregnant, nursing, or possibly pregnant women, or women desiring to become pregnant during the study period.
- Participation in any investigational study within 4 weeks preceding the start of study treatment.
- Other cases judged by the investigator to be ineligible for participation in the study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
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: CCRT Arm
Patients recruited will be treated by concurrent chemoradiotherapy with IGRT and two cytotoxic agents: capecitabine and oxaliplatin.
Capecitabine will be taken orally twice a day, from D1 to D14 while oxaliplatin will be given intravenously on D1 and D8, every 21 days.
The doses of the two drugs will be escalated alternatively in each level group.
The radiation will be given by IGRT and the dose is between 45 to 54Gy, 1.8-3Gy per fraction.
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IGRT: 45 to 54Gy, 1.8-3Gy per fraction.
Andre navn:
Capecitabine: by oral, D1-14, every 21 days, 600mg/m2 bid per day in level 1, and then escalated every another dose level.
Andre navn:
Oxaliplatin: intravenously, D1 and D8, every 21 days, 30mg/m2 per day in level 1, and then escalated every another dose level.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Maximum Tolerated Dose (MTD) for capecitabine and oxaliplatin
Tidsramme: up to four weeks after the end of the treatment.
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up to four weeks after the end of the treatment.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Dose Limiting Toxicity (DLT)
Tidsramme: up to four weeks after the end of the treatment.
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up to four weeks after the end of the treatment.
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In field recurrence rate (LR) or local failure free survival (LFFS)
Tidsramme: From the completion of CCRT to 6, 12, 24, 36 months afterward.
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From the completion of CCRT to 6, 12, 24, 36 months afterward.
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Intrahepatic failure rate or intrahepatic failure free survival (IHFFS)
Tidsramme: From the completion of CCRT to 6, 12, 24, 36 months afterward.
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From the completion of CCRT to 6, 12, 24, 36 months afterward.
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Extrahepatic failure rate or extrahepatic failure free survival (EHFFS)
Tidsramme: From the completion of CCRT to 6, 12, 24, 36 months afterward.
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From the completion of CCRT to 6, 12, 24, 36 months afterward.
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Overall survival
Tidsramme: From the completion of CCRT to 6, 12, 24, 36 months afterward.
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From the completion of CCRT to 6, 12, 24, 36 months afterward.
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Tumor response rate including complete response and partial response rates
Tidsramme: 1 month and 3 month from the end of CCRT
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1 month and 3 month from the end of CCRT
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Jing Jin, doctor, Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2013
Primær fullføring (Forventet)
1. juni 2016
Studiet fullført (Forventet)
1. desember 2016
Datoer for studieregistrering
Først innsendt
24. mars 2015
Først innsendt som oppfylte QC-kriteriene
26. mars 2015
Først lagt ut (Anslag)
31. mars 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
5. januar 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. januar 2016
Sist bekreftet
1. januar 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Adenokarsinom
- Neoplasmer, kjertel og epitel
- Neoplasmer i fordøyelsessystemet
- Leversykdommer
- Neoplasmer i leveren
- Karsinom
- Karsinom, hepatocellulært
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Capecitabin
- Oksaliplatin
Andre studie-ID-numre
- CH-GI-048
- 13-102/778 (Annen identifikator: Ethics Committee of Cancer Institute and Hospital)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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