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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 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

6

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Aktiv 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate (ORR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai 6th People's Hospital

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: 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.

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 (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. december 2029

Studieafslutning (Anslået)

31. december 2030

Datoer for studieregistrering

Først indsendt

3. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-086-(1)

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Kliniske forsøg med Intrahepatisk cholangiocarcinom (Icc)

Kliniske forsøg med Celecoxib + Pembrolizumab + Gemcitabine/Cisplatin

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