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A Multicenter, Prospective, Randomized, Open-label Phase Ib/II Study of Celecoxib Plus Pembrolizumab and Gemcitabine/Cisplatin Versus Pembrolizumab and Gemcitabine/Cisplatin in Patients With CK5/6-High Unresectable Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma

8. Juni 2026 aktualisiert von: Haiyan hu, Shanghai 6th People's Hospital

This study aims to evaluate whether adding celecoxib to standard therapy can improve clinical outcomes in patients with advanced intrahepatic cholangiocarcinoma. The current standard treatment typically consists of immunotherapy combined with chemotherapy; however, there are significant inter-patient differences in treatment response. Therefore, this study further introduces the biomarker CK5/6 to identify patient subgroups who are more likely to benefit, thereby exploring a more precise therapeutic strategy.

All eligible participants will be randomly assigned after enrollment to either the control group or the experimental group. The control group will receive the current standard first-line regimen, which includes the immunotherapy agent pembrolizumab combined with the chemotherapy agents gemcitabine and cisplatin. The experimental group will receive the same standard treatment, with the addition of oral anti-inflammatory therapy with celecoxib taken twice daily throughout the entire treatment period.

Each treatment cycle lasts 21 days. During treatment, patients will undergo regular imaging assessments, laboratory tests, and safety evaluations to monitor tumor response and treatment-related adverse events, and will be followed until disease progression or discontinuation of treatment. In addition, blood and tissue samples will be collected during the study to investigate tumor biology and potential predictive biomarkers.

The primary endpoints of this study include progression-free survival and objective response rate, along with concurrent safety evaluation. Adverse events potentially associated with chemotherapy, immunotherapy, and celecoxib may occur, such as bone marrow suppression, gastrointestinal reactions, immune-related inflammatory responses, as well as renal or cardiovascular toxicities. The study team will closely monitor and promptly manage all adverse events.

This study aims to explore a CK5/6-based stratified personalized combination therapy strategy, with the goal of improving treatment benefit in patients with advanced intrahepatic cholangiocarcinoma and providing evidence for optimizing future clinical treatment strategies.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

6

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histologically or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA).
  • Unresectable locally advanced, recurrent, or metastatic disease.
  • No prior systemic therapy for advanced disease.
  • At least one measurable lesion according to RECIST v1.1.
  • ECOG performance status of 0-1.
  • Availability of adequate pre-treatment tumor tissue for central pathological review.
  • CK5/6 H-score ≥ 1.0 as determined by central laboratory testing.
  • Adequate organ and bone marrow function as defined by protocol-specified laboratory criteria.
  • Patients with biliary obstruction must have undergone effective drainage and achieved clinical stabilization prior to enrollment.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Other primary malignancies including extrahepatic cholangiocarcinoma, gallbladder carcinoma, or ampullary carcinoma.
  • CK5/6 H-score < 1.0.
  • Prior systemic therapy for advanced or metastatic disease.
  • Active gastrointestinal bleeding, peptic ulcer disease, or high risk of gastrointestinal perforation.
  • Recent history of significant cardiovascular events including myocardial infarction, stroke, uncontrolled hypertension, or severe heart failure.
  • Known hypersensitivity to celecoxib, sulfonamides, NSAIDs, or aspirin-exacerbated respiratory disease.
  • Active autoimmune disease or conditions contraindicating pembrolizumab therapy.
  • Severe renal impairment.
  • Child-Pugh class C hepatic impairment.
  • Active uncontrolled infection.
  • Any condition that, in the investigator's opinion, would interfere with study participation or interpretation of results.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Experimental: Celecoxib + Pembrolizumab + Gemcitabine/Cisplatin
Participants receive celecoxib in combination with pembrolizumab and gemcitabine/cisplatin chemotherapy. Celecoxib is administered orally at 200 mg twice daily continuously starting from Cycle 1 Day -7. Pembrolizumab is administered intravenously at 200 mg on Day 1 of each 21-day cycle. Gemcitabine (1000 mg/m²) and cisplatin (25 mg/m²) are administered intravenously on Day 1 and Day 8 of each cycle. Cisplatin is given for up to 8 cycles. Treatment is continued until disease progression, unacceptable toxicity, or withdrawal.
Arzneimittel: Celecoxib + Pembrolizumab + Gemcitabine/Cisplatin
Celecoxib is administered orally at a dose of 200 mg twice daily continuously in the experimental arm. Treatment is initiated at Cycle 1 Day -7 and continued until disease progression, unacceptable toxicity, or withdrawal.
Aktiver Komparator: Active Comparator: Pembrolizumab + Gemcitabine/Cisplatin
Participants receive pembrolizumab in combination with gemcitabine/cisplatin chemotherapy. Pembrolizumab is administered intravenously at 200 mg on Day 1 of each 21-day cycle. Gemcitabine (1000 mg/m²) and cisplatin (25 mg/m²) are administered intravenously on Day 1 and Day 8 of each cycle. Cisplatin is given for up to 8 cycles. Treatment is continued until disease progression, unacceptable toxicity, or withdrawal.
Arzneimittel: Pembrolizumab + Gemcitabine/Cisplatin
Participants receive pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in combination with gemcitabine 1000 mg/m² and cisplatin 25 mg/m² administered intravenously on Days 1 and 8 of each cycle. Cisplatin is administered for up to 8 cycles. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-Free Survival (PFS)
Zeitfenster: Up to 24 months
Progression-free survival (PFS) is defined as the time from randomization to the first documented disease progression per RECIST v1.1 criteria or death from any cause, whichever occurs first. Disease progression will be assessed by imaging review according to RECIST v1.1 in both treatment arms.
Up to 24 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Objective Response Rate (ORR)
Zeitfenster: Up to 24 months
Objective response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed by investigators according to RECIST v1.1 criteria in both treatment arms.
Up to 24 months
Disease Control Rate (DCR)
Zeitfenster: Up to 24 months
Disease control rate is defined as the proportion of participants achieving complete response, partial response, or stable disease according to RECIST v1.1 criteria.
Up to 24 months
Overall Survival (OS)
Zeitfenster: Up to 36 months
Overall survival is defined as the time from randomization to death from any cause.
Up to 36 months
Duration of Response (DoR)
Zeitfenster: Up to 24 months
Duration of response is defined as the time from first documented objective response (CR or PR) to disease progression or death.
Up to 24 months
Safety and Tolerability
Zeitfenster: From first dose until 30 days after last treatment
Safety and tolerability will be assessed by incidence, severity, and type of adverse events graded according to CTCAE v5.0.
From first dose until 30 days after last treatment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Shanghai 6th People's Hospital

Mitarbeiter

RenJi Hospital
Shanghai 10th People's Hospital
Wuhan TongJi Hospital
Sun Yat-Sen University Cancer Center

Ermittler

  • Hauptermittler: cun wang, State Key Laboratory of Systems Medicine for Cancer, Shanghai Cancer Institute & Department of Liver Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2029

Studienabschluss (Geschätzt)

31. Dezember 2030

Studienanmeldedaten

Zuerst eingereicht

3. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Juni 2026

Zuerst gepostet (Tatsächlich)

8. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026-086-(1)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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