- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04970914
Anlotinib Plus Penpulimab (AK105) for Chemo-refractory Metastatic Colorectal Cancer:ALTER-C003 (ALTER-C003)
6. mars 2022 oppdatert av: YueJuan Cheng, Peking Union Medical College Hospital
Anlotinib Hydrochloride In Combination With Penpulimab (AK105) in Patients With Chemo-refractory Metastatic Colorectal Cancer, Open, Single Arm,Exploratory Clinical Trial(ALTER-C003)
A single-arm, open-label clinical trial, focus on the safety and efficacy of anlotinib hydrochloride in combination with Penpulimab (AK105) in patients with Chemo-refractory Metastatic Colorectal Cancer (mCRC)
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
32
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jianfeng Zhou
- Telefonnummer: 011-86-10-69156114
- E-post: ZhouJF@pumch.cn
Studiesteder
-
-
-
Beijing, Kina
- Rekruttering
- Peking Union Medical College Hospital
-
Ta kontakt med:
- jianfeng Zhou
- E-post: ZhouJF@pumch.cn
-
Shenyang, Kina
- Har ikke rekruttert ennå
- The First Hospital of China Medical University
-
Ta kontakt med:
- Xiujuan Qu
-
Shenyang, Kina
- Har ikke rekruttert ennå
- The People's Hospital of Liaoning Province
-
Ta kontakt med:
- Du Zhenguang
-
-
Beijing
-
Beijing, Beijing, Kina
- Rekruttering
- Beijing Tiantan Hospital, Capital Medical University
-
Ta kontakt med:
- Xiaoyuan Li
-
Hovedetterforsker:
- Xiaoyuan Li
-
Beijing, Beijing, Kina
- Har ikke rekruttert ennå
- China-Japan Friendship Hospital
-
Hovedetterforsker:
- Yuan Li
-
Ta kontakt med:
- Yuan Li
-
-
Hebei
-
Langfang, Hebei, Kina
- Har ikke rekruttert ennå
- Hebei Petro China Central Hospital
-
Ta kontakt med:
- Qian Guo
-
Hovedetterforsker:
- Qian Guo
-
Shijiazhuang, Hebei, Kina
- Har ikke rekruttert ennå
- The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital)
-
Hovedetterforsker:
- Ruixing Zhang
-
Ta kontakt med:
- Ruixing Zhang
- Telefonnummer: 0086-311-86095757
-
-
Tianjin
-
Tianjin, Tianjin, Kina
- Rekruttering
- General Hospital of Tianjin Medical University
-
-
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 og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients participate in the study voluntarily and sign informed consent with good compliance.
- Be 18 years of age or older on day of signing informed consent.
- Histological or cytological confirmation of Metastatic Colorectal Cancer(T1-4N0-2M1).
- At least one measurable lesion, with diameter ≥ 10mm measured by spiral MRI/CT scan per RECIST1.1.
- Participants must have received and progressed through or become intolerant to fluoropyrimidine, irinotecan, oxaliplatin, Exceptions may apply.
- Eastern Cooperative Oncology Group Performance Status 0 or 1.
- Life expectancy of at least 3 months.
- Main organs function is normal. (normal main organs function as defined below: Hemoglobin (Hb) ≥ 90 g/L, Neutrophils (ANC) ≥ 1.5×109/L, leucocyte (WBC) ≥ 3.0×109/L,Platelet count (PLT) ≥ 75×109/L,Total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 ×ULN, If liver metastasis is present,ALT and AST<5ULN ;Serum creatinine (Cr) ≤ 1.5× ULN or Creatinine Clearance rate(CCr) ≥60ml/min,Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) > 50%)
- The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 3 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after it.
Exclusion Criteria:
- Histological or cytological confirmation of mucinous adenocarcinoma or ovarian transcoelomic metastasis
- Patients who had previously received treatment with Anlotinib or anti-programmed cell death protein 1 (PD-1), programmed cell death protein 1 ligand 1 (PD-L1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors other immunotherapy against .
- Patients who had previously received treatment within 2 weeks or Participated in other anti-tumor clinical trials within 4 weeks.
- Patients with a large amount of pleural effusion or ascites requiring drainage.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- Patients who underwent major surgery within 4 weeks.
- Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers.
- Patients with a risk of gastrointestinal bleeding may not be enrolled.
- Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism.
- Patients with any severe and/or unable to control diseases,including: Patients with unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100) mmHg); Patients with Grade 2 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including male QTc≥450ms; female QTc≥470ms) and patients with Grade 2 or higher congestive heart failure (NYHA Classification); Patients with active or unable to control serious infections, which is over level 2 in CTC AE (4.0); Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L); Patients with kidney failure who require hemodialysis or peritoneal dialysis; Patients with interstitial lung disease with symptoms or signs of activity;Patients with a history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation > 1.0 g; Patients with any of the following coagulation functions are abnormal, including: Prothrombin time (PT)>ULN+4s, Activated partial thromboplastin time (APTT) >1.5ULN s, international normalized ratio (INR)>1.5; Patients with a seizure disorder who require pharmacotherapy.
- Patients who have got non remissive toxic reactions derived from any treatment, which is over level 1 in CTC AE (4.0).
- Has a diagnosis of immunodeficiency or is receiving chronic steroid therapy of prednisone ≥ 10 mg daily or any equivalent dose of corticosteroids.
- Has received a live vaccine or attenuated vaccine within 30 days prior to trial registration.
- Symptoms that affect oral medication and cannot be controlled through proper treatment (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.).
- Female patients who are pregnant or breastfeeding.
- Patients with drug abuse history and unable to get rid of or patients with mental disorders.
- Patients who had serious adverse effect to Anlotinib or Penpulimab or any of its excipients
- Known hypersensitivity to other Monoclonal Antibody or any of its excipients.
- Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment.
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: Anlotinib+Penpulimab
|
Penpulimab 200 mg administrert intravenøst hver 3. uke.
Andre navn:
12 mg, kontinuerlig oral 2 ukers stopp i 1 uke, 21 dager for en behandlingssyklus.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Progression-free survival (PFS)
Tidsramme: up to 24 months
|
Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
|
up to 24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Disease Control Rate (DCR)
Tidsramme: opptil 24 måneder
|
Sykdomskontrollrate er definert som prosentandelen av forsøkspersoner hvis beste respons var CR, PR eller stabil sykdom (SD) i henhold til RECIST v1.1.
|
opptil 24 måneder
|
Objective Response Rate (ORR)
Tidsramme: up to 24 months
|
Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the RECIST v1.1
|
up to 24 months
|
Duration of Response (DOR)
Tidsramme: up to 24 months
|
Duration of Response is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1 or death due to any cause, whichever occurs first.
|
up to 24 months
|
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Tidsramme: Until 30 day safety follow-up visit
|
Adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
|
Until 30 day safety follow-up visit
|
Overall Survival (OS)
Tidsramme: Up to 24 months
|
Overall Survival (OS) (median) is determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.
|
Up to 24 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of TB cells count and interleukin-6/8/10
Tidsramme: through study completion, an average of 2 year
|
Objectives to analyse the subsets of TB cells and interleukin-6/8/10 associated treatment.
|
through study completion, an average of 2 year
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Jianfeng Zhou, Peking Union Medical College Hospital
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 (Faktiske)
5. november 2021
Primær fullføring (Forventet)
23. august 2022
Studiet fullført (Forventet)
23. august 2023
Datoer for studieregistrering
Først innsendt
5. juli 2021
Først innsendt som oppfylte QC-kriteriene
13. juli 2021
Først lagt ut (Faktiske)
21. juli 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. mars 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. mars 2022
Sist bekreftet
1. mars 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HS-2986B
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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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-
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