NCT07896096Toboroz2. fázis
Ivarmacitinib Combined With Camrelizumab and Fruquintinib for Patients With Metastatic Colorectal Cancer After Failure of Second-line or Later Treatment
A Phase II Study of Ivarmacitinib Combined With Camrelizumab and Fruquintinib for Patients With Metastatic Colorectal Cancer After Failure of Second-line or Later Treatment
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 28.
Rövid összefoglaló (regiszter, angolul)
For patients with metastatic colorectal cancer (mCRC) who have failed two or more lines of standard therapy, treatment options are extremely limited, and the prognosis remains poor, with objective response rates (ORRs) generally below 5%. This is particularly challenging for patients with microsatellite-stable (MSS)/proficient mismatch repair (pMMR) tumors, who constitute the vast majority of patients with mCRC. The immunologically "cold" tumor microenvironment (TME) in these patients contributes to widespread primary resistance to PD-1 inhibitor monotherapy. A key mechanism underlying this resistance is the sustained activation of JAK/STAT signaling, which promotes immunosuppression mediated by myeloid-derived suppressor cells (MDSCs) and other immunosuppressive components, thereby limiting T-cell activity and the efficacy of strategies that solely reinvigorate T cells. To address this challenge, the investigators propose an innovative combination strategy aimed at remodeling the TME and alleviating immunosuppression. The investigators hypothesize that ivarmacitinib, a highly selective JAK1 inhibitor, may attenuate the immunosuppressive TME through modulation of JAK/STAT signaling, potentially converting "cold" tumors into "hot" tumors and enhancing the antitumor activity of camrelizumab, a PD-1 inhibitor, in combination with fruquintinib, a tyrosine kinase inhibitor (TKI). Accordingly, a single-arm, single-center, exploratory phase II clinical study was designed to enroll 33 patients with mCRC who have failed multiple lines of prior therapy. The study aims to evaluate the ORR, survival outcomes, and safety of this combination regimen. The findings are expected to provide preliminary evidence for a potential new therapeutic approach for this heavily pretreated patient population and establish a foundation for subsequent larger confirmatory studies.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 33 (tervezett)
- Első benyújtás
- 2026. okt. 20.
- Kezdés
- 2026. ápr. 14.
- Elsődleges befejezés
- 2027. dec. 30.
- Fő szponzor
- Renmin Hospital of Wuhan University
- Betegségek
- Vastagbélrák
- NCT-szám
- NCT07896096
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 33
- 2026. ápr. 14. és az elsődleges befejezés (2027. dec. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Prior treatment with a JAK1 inhibitor.
- Active autoimmune disease or primary immunodeficiency within the previous 2 years.
- Major cardiovascular or cerebrovascular diseases, including stroke or myocardial infarction within 6 months before enrollment, uncontrolled hypertension, unstable angina, heart failure (New York Heart Association [NYHA] class II-IV), or severe arrhythmias requiring pharmacological treatment.
- Toxicities from previous anticancer treatment that have not recovered to Grade 1 or lower, except for alopecia.
Más betegség
- History of other malignancies within 5 years before enrollment, except for excised basal cell carcinoma of the skin or cervical carcinoma in situ.
- Membership in vulnerable populations, including individuals with mental or cognitive impairment, critically ill patients, minors, pregnant or breastfeeding women.
- Severe chronic obstructive pulmonary disease (COPD), interstitial lung disease, or other conditions that severely impair pulmonary function.
- History of venous thrombosis.
- Active tuberculosis or active bacterial, fungal, or viral infection.
Laborértékek
- Known allergy to monoclonal antibodies, sodium carboxymethylcellulose, or any of their components.
- Severe hepatic impairment, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × the upper limit of normal (ULN) in patients without liver metastases, or ≥ 5 × ULN in patients with liver metastases.
- Severe renal impairment, defined as creatinine clearance (CrCl) < 30 mL/min.
Kiket keres a vizsgálat
- Histologically or cytologically confirmed advanced, metastatic, or recurrent colorectal cancer, supported by radiological findings.
- Age 18-75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Disease progression or failure of at least second-line standard therapy.
- Voluntary provision of written informed consent.
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Renmin Hospital of Wuhan University | Wuhan | Kína | Toboroz |
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