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- Klinische proef NCT04814485
Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer
A Prospective, Single-center Clinical Study to Explore the Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This trial is a prospective, single-center, single-arm clinical research. Advanced pancreatic cancer is an aggressive disease with extremely low 5-year survival rate. For advanced pancreatic cancer patients who failed with first-line treatment, subsequent treatment options are limited. SHR-1020 combined with albumin-bound paclitaxel could through multiple mechanisms such as block tumor mitosis, inhibit tumor angiogenesis, inhibit interstitial fibrosis to achieve anti-tumor effect.
The safety and efficacy of this study will be assessed through ORR, DCR,PFS, OS , and adverse effects as graded by CTCAE 5.0.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
-
-
Tianjin
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Tianjin, Tianjin, China, 300000
- Werving
- Tianjin Medical University Cancer Institute and Hospital
-
Contact:
- jihui Hao, MD
- Telefoonnummer: 022-23524155
- E-mail: ec_tjcih@126.com
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Contact:
- chuntao Gao, MD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients who were diagnosed as metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma by histopathology or cytology, at least one measurable lesion conforming to RECIST 1.1 criteria.
- Disease progresses or intolerance for first-line standard treatment, including patients who relapsed or metastasized within 6 months of neoadjuvant or adjuvant therapy
- ECOG score 0-2
- Adequate organ and bone marrow function
- The expected survival time is ≥ 12 weeks
- Had normal swallowing function, without dysfunction of gastrointestinal absorption
- Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures
Exclusion Criteria:
- The patient has previously received anti-angiogenic drugs or albumin-bound paclitaxel;
- The first study drug treatment was less than 2 weeks or 5 half-lives (in terms of longer) from the last chemotherapy or 5 half-lives from the last targeted therapy
- Known to be allergic to the active ingredients or excipients in this study.
- Had other active malignant tumors within 5 years before entering the study.
- Subject with cerebral metastasis
- Have a clear history of serious and uncontrolled other disease or mental disorders;
- Other chemotherapy, targeted therapy, hormonotherapy, immunotherapy, radiotherapy or traditional Chinese medicine should be used for anti-tumor therapy
- Other situations that the researcher considers inappropriate to participate in the research.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: SHR-1020 combined with albumin-bound paclitaxel
|
SHR-1020 combined with albumin-bound paclitaxel for advanced pancreatic cancer
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
ORR (Objective Response Rate)
Tijdsspanne: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
|
Containing the incidence of complete response (CR) and partial response (PR).
Evaluated according to RECIST 1.1 criteria,subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
|
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
DCR (Disease Control Rate)
Tijdsspanne: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
|
Containing the incidence of complete response (CR), partial response (PR) and stable disease (SD).Evaluated according to RECIST 1.1 criteria,subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
|
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
|
PFS (Progression-Free-Survival)
Tijdsspanne: From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months
|
From date of treatment start until the date of progression or the date of death due to any cause.Evaluated according to RECIST 1.1 criteria,subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
|
From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months
|
6mPFS
Tijdsspanne: Up to 6 months
|
6-month- Progression-Free-Survival rate.
Evaluated according to RECIST 1.1 criteria,subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
|
Up to 6 months
|
OS (overall survival)
Tijdsspanne: From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 12 months
|
From date of treatment start to any cause death or last follow-up.
|
From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 12 months
|
Adverse events (per CTCAE v5.0 criteria)
Tijdsspanne: Up to 12months
|
To evaluate the adverse events of patients with advanced pancreatic cancer after treated with SHR-1020 plus albumin-bound paclitaxel
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Up to 12months
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata
- Neoplasmata per site
- Endocriene systeemziekten
- Neoplasmata van het spijsverteringsstelsel
- Endocriene klierneoplasmata
- Alvleesklier Ziekten
- Pancreasneoplasmata
- Moleculaire mechanismen van farmacologische werking
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, fytogeen
- Paclitaxel
- Albumine-gebonden paclitaxel
Andere studie-ID-nummers
- PANC-2nd-IIT-FMTN-naP
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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