- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04389151
Triplezumab Combined With CAPEOX Regimen in Neoadjuvant Therapy for Locally Advanced Colon Cancer
11. maj 2020 opdateret af: The First Affiliated Hospital of Xiamen University
Triplezumab Combined With CAPEOX Regimen Was Used in a Phase II Clinical Study of Neoadjuvant Therapy for Locally Advanced Colon Cancer With MSI-H /dMMR
According to the 2019NCCN guidelines, immunocheckpoint inhibitors are recommended for first-line treatment of metastatic colon cancer patients with high microsatellite instability (msi-h) or mismatched gene deletion (dMMR) who are not suitable for intensive treatment, and for all patients with second-line or above msi-h /dMMR treatment.This study is a single-center, single-arm phase II study of the use of triplezumab (JS001) combined with CAPEOX regimen in the neoadjuvant therapy of msi-h /dMMR for locally advanced colon cancer.
The subjects received neoadjuvant therapy with triplezumab (JS001) combined with CAPEOX regimen, with one treatment cycle every 3 weeks and two cycles of surgery followed by pathological evaluation.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
30
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Fujian
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Xiamen, Fujian, Kina, 361003
- Rekruttering
- Yefeng
-
Kontakt:
- Ye feng, Master
-
-
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Sign written informed consent.
- Age ≥18 years.
- ECOG physical condition score ≤1.
- Pathological diagnosis of msi-h /dMMR colon cancer.
- The TNM stage of colon cancer was ct3/4nxm0 or ctxn1/2m0.
- Never received anti-tumor treatment including but not limited to radiotherapy, chemotherapy and surgery.
The patient must have adequate organ function and meet the following laboratory test values during the screening period within 7 days before enrolling:
- Absolute neutrophil cell count (ANC) ≥1.5x109/L, platelet ≥100x109/L, hemoglobin ≥90g/L.(in (Patients with no blood transfusion or growth factor support should be given for 7 days prior to blood collection.)
- Serum creatinine ≤1.5× upper normal range (ULN) or estimated creatinine clearance ≥50mL/min.
- Total bilirubin ≤1.5×ULN;If there is Gilbert syndrome or if the indirect bilirubin concentration indicates an extrahepatic source of bile The rise of erythrosin is ≤3×ULN.
- Glutamate aminotransferase and glutamate aminotransferase (AST and ALT)≤3×ULN.
- Aptt ≤1.5×ULN, and INR or PT≤1.5×ULN.
- Fertile women must be willing to participate in the final CAPEOX programme during the study period and in conjunction with the triplezumab (JS001) Contraceptive measures were taken at least 120 days after administration, and urine or serum pregnancy tests were negative for 7 days prior to enrollment.
- Unsterilized male subjects must be willing to participate during the study and at the end of the triplezumab (JS001) combined CAPEOX regimen Use contraception for at least 120 days after the first dose.
- Good compliance, agreed to cooperate with the survival follow-up.
Exclusion Criteria:
- Signs of distant metastasis.
- The presence of complete obstruction, massive bleeding, or perforation associated with a colon tumor.
- Previous use of immunocheckpoint inhibitors targeting ctla-4, pd-1 or pd-l1.
- Have radiotherapy plan before or after operation.
- A history of research on drug ingredients and severe allergic reactions to any monoclonal antibody.
- Severe infection in the active stage or poorly controlled clinically.
- Symptomatic congestive heart failure (New York heart association grade ii-iv) or symptomatic, poorly controlled arrhythmia often; Any arterial thromboembolic events that occurred or occurred within 6 months prior to inclusion included myocardial infarction, unstable angina cerebrovascular accident or transient ischemic attack; Deep vein thrombosis, pulmonary embolism, or any other serious condition occurred 3 months prior to enrollment, History of thromboembolism (implantable venous infusion port or catheter-induced thrombosis, or superficial venous thrombosis is not seen severe thromboembolism).
- Subjects with any active, known or suspected autoimmune disease.History of autoimmune disease, including but not limited myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis related to antiphospholipid syndrome, wegener's granulomatosis, sjogren's syndrome, guillain-barre complex signs, multiple sclerosis, vasculitis, or glomerulonephritis.
- Patients with autoimmune hypothyroidism who receive stable dose hormone replacement therapy are eligible to participate in this study investigate.
- Patients with vitiligo or who have had complete remission of childhood asthma may be included without any intervention in adulthood.
- Asthma patients requiring intermittent use of bronchodilators, inhaled steroids, or topical injections were not excluded from the study outside.
- Use of corticosteroids (>10mg/ day prednisone or equivalent) or other within 14 days prior to initial administration subjects who received systemic therapy with immunosuppressive agents.In the absence of active autoimmune disease, inhalation or topical administration of corticosteroids and adrenal hormone replacement at dose ≤10mg/ day of prednisone.
- Subjects with highly suspected interstitial lung disease, or interstitial lung disease requiring steroid hormone therapy, or other severe cases were excluded diseases that seriously affect lung function.
- Get a live vaccine 4 weeks before joining.
- Patients with other active malignancies within 5 years prior to the first use of the study drug.Localized tumors that have been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc into the group.
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: The experimental group
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Toripalimab union CAPEOX scheme: Toripalimab 240mg, ivgtt, Q3w Oxaliplatin 130mg/m2,ivgtt, Q3w capecitabine 1000mg/m2, p.o Q3w
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
effectiveness of neoadjuvant therapy
Tidsramme: 6 weeks
|
The main pathological response rate of neoadjuvant therapy
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6 weeks
|
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 (Faktiske)
4. marts 2020
Primær færdiggørelse (Forventet)
4. marts 2021
Studieafslutning (Forventet)
4. marts 2021
Datoer for studieregistrering
Først indsendt
28. april 2020
Først indsendt, der opfyldte QC-kriterier
11. maj 2020
Først opslået (Faktiske)
15. maj 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. maj 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. maj 2020
Sidst verificeret
1. april 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- JS001-ISS-CO24
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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