OncoMatch/Clinical Trials/NCT07786766
Pemigatinib Plus PD-1 Inhibitor With or Without Chemotherapy in FGFR2 Fusion/Rearrangement-Positive Cholangiocarcinoma
Is NCT07786766 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Pemigatinb and PD-1 inhibitors for biliary tract cancer (btc).
Treatment: Pemigatinb · PD-1 inhibitors · Chemotherapy — This is a prospective, single-arm, phase II clinical study. Patients with advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements who have either not previously received standard therapy or have experienced treatment failure following standard therapy will be screened for eligibility and enrolled in the study after providing written informed consent.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Cholangiocarcinoma
Biomarker criteria
Required: FGFR2 fusion
Histologically confirmed FGFR2 fusion or rearrangement
Required: FGFR2 rearrangement
Histologically confirmed FGFR2 fusion or rearrangement
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: FGFR inhibitor (pemigatinib, futibatinib)
No prior treatment with a selective FGFR inhibitor, including pemigatinib, futibatinib, or other selective FGFR inhibitors.
Cannot have received: FGFR inhibitor
Prior treatment with a selective FGFR inhibitor.
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L (no G-CSF within 14 days); Platelet count ≥ 90 × 10⁹/L (no transfusion within 14 days); Hemoglobin > 9 g/dL (no transfusion or ESA within 14 days)
Kidney function
Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min
Liver function
Total bilirubin ≤ 2.5 × ULN; AST and ALT ≤ 3.0 × ULN (≤ 5.0 × ULN with liver metastases)
Cardiac function
Adequate coagulation function (INR or PT ≤ 1.5 × ULN; patients on anticoagulant therapy eligible if PT within intended therapeutic range); no clinically significant or uncontrolled cardiac disease (unstable angina, recent MI, NYHA III/IV CHF, uncontrolled arrhythmia, significant ECG abnormalities)
Adequate organ function, defined by the following laboratory criteria: ... see inclusion criterion 8 and exclusion criterion 11
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07786766 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior FGFR inhibitor, FGFR inhibitor disqualifies patients from enrollment.
Does this trial require FGFR2?
Yes, FGFR2 fusion is a required biomarker for enrollment.
Does this trial require FGFR2?
Yes, FGFR2 rearrangement is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages