- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01180153
Study of S-1 Oxaliplatin (SOX) for Biliary Tract Cancer (BTC) (Ampullary Adenocarcinoma)
11. august 2010 opdateret af: Peking University Cancer Hospital & Institute
An Pilot Study of S-1 Combined With Oxaliplatin for First-line Treatment of Unresectable, Metastatic or Locally Advanced Biliary Tract Cancer or Ampullary Adenocarcinoma
To evaluate efficacy and safety of S-1 Oxaliplatin (SOX) regimen to patients with unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma.
Studieoversigt
Detaljeret beskrivelse
To list in cases with unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma that have not been treated before,confirm the efficacy and safety of combined S-1/L-OHP regimen for the biliary tract or ampullary carcinoma, providing evidence-based proof for the future treatment.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
40
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Beijing
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Beijing, Beijing, Kina, 100004
- Chin Beijing Cancer Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 74 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Informed consent has been signed by the subject itself;
- Aged over 18;
- With a definite pathological or cytological diagnosis of adenocarcinoma;
- No pre-treatment (including radiotherapy, chemotherapy, immunotherapy, etc.). For recurrent cases, if the subjects have received adjuvant chemotherapy without S-1 or L-OHP after surgery and the time to the end date of adjuvant chemotherapy is over 6 months, they can also be enrolled;
- Enhanced helical CT or MRI scanning shows a target lesion over 1cm within 14 days before enrollment
Within 7 days before enrollment, baseline blood routine and biochemical indicators meet the following criteria:
- Hemoglobin ≥ 90g/L,
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L,
- Platelets ≥ 100×109/L,
- Serum total bilirubin < 1.5 times of the upper normal limit,
- Serum creatinine < upper limit of normal,
- Serum albumin ≥ 30 g/L;
- Can receive oral administration;
- Karnofsky(KPS) score ≥ 70 points;
- Expected survival time is more than 90 days;
- Women of childbearing age must receive urine or blood pregnancy test within 7 days before randomization and the results are negative;
- Male and female patients of appropriate reproductive age are willing to use reliable contraception methods for contraception in the process of study till 30 days after drug withdrawal.
Exclusion Criteria:
- Patients with a severe drug allergy history (including mildly allergic to L-OHP, 5-FU, FT207, 5-HT3 receptor antagonist);
- Patients who participated or are participating in other clinical trials within 4 weeks before enrollment;
- Patients who have received blood transfusion, blood products and hematopoietic factor preparations such as G-CSF within 15 days before enrollment;
- Patients who have undergone a surgery within 15 days before enrollment, and its effects have not been eliminated;
- Patients with diarrhea;
- Patients with a complication of active infection (infection causes a fever above 38 ℃);
- Patients accompanied by dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding and perforation, etc. that cause difficulty in taking S-1 orally;
- Patients with severe liver disease (e.g. active hepatitis, cirrhosis, etc.), renal insufficiency, severe lung disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.), or uncontrollable diabetes, hypertension and other chronic systemic diseases;
- Patients who have received long-term systemic steroid therapy (Note: short-term users with steroid withdrawal > 2 weeks can be selected);
- Patients with brain metastases or suspected of brain metastases;
- Patients with peripheral nervous system disorder or a history of significant mental disorder and central nervous system disorder;
- Heart disease of significant clinical symptoms, e.g. congestive heart failure, coronary heart disease with significant symptoms, arrhythmia and hypertension that are difficult to be controlled by drugs, or with an episode of myocardial infarction within 6 months, or cardiac insufficiency;
- Patients with pleural effusion, ascites, or pericardial effusion that needs drainage;
- Pregnant or breast-feeding women, or male and female patients of appropriate reproductive age who refuse to take contraceptive measures;
- Patients who have suffered from other malignancies within 5 years, except basal cell carcinoma and carcinoma in situ of uterine cervix that have already been cured;
- Patients without legal capability, or who can not continue the study due to medical or ethical reasons;
- Patients who are determined not suitable to participate in this clinical trial by the investigators.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: SOX: advanced BTC or ampullary carcinoma
unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma receive SOX regimen
|
S-1 (20mg, 25mg); L-OHP (50 mg)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
objective response rate
Tidsramme: 2 years
|
to evaluate objective response rate (ORR) of SOX regimen to BTC (Ampullary Adenocarcinoma)
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2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
overall survival
Tidsramme: 2 years
|
to evaluate survival data of overall survival (OS),Progression free Survival(PFS), safety outcome of SOX regimen to BTC (Ampullary Adenocarcinoma)
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2 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2010
Primær færdiggørelse (Forventet)
1. august 2012
Studieafslutning (Forventet)
1. august 2012
Datoer for studieregistrering
Først indsendt
9. august 2010
Først indsendt, der opfyldte QC-kriterier
11. august 2010
Først opslået (Skøn)
12. august 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. august 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. august 2010
Sidst verificeret
1. august 2010
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ChinaBJCH_SOX_BTC
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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