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OncoMatch/Clinical Trials/NCT06662006

Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients

Is NCT06662006 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies nal-IRI,5-fu,LV, benmelstobart, anlotinib for advanced metastatic pancreatic cancer.

Phase 2RecruitingThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolNCT06662006Data as of Jun 2026Location: China

Treatment: nal-IRI,5-fu,LV, benmelstobart, anlotinibThis study is a single-arm, multi-center, multi-cohort, prospective clinical study initiated by the investigator. The indication of this study is: patients with advanced metastatic pancreatic cancer who have progressed after first-line chemotherapy. Eligible patients will be assigned to liposomal irinotecan (nal-IRI) plus 5-fluorouracil (5-FU)/leucovorin (LV) (nal-IRI/5-FU/LV) combined with benmelstobart and anlotinib ± SBRT. The total sample size for this study is expected to be 56 subjects.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

nal-IRI,5-fu,LV, benmelstobart, anlotinib

Cancer type

Pancreatic Cancer

Disease stage

Required: Stage IV

Metastatic disease required

advanced metastatic pancreatic cancer; Imaging suggests distant measurable lesions

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 75

Prior therapy

Max 1 prior line
Min 1 prior line

Must have received: first-line therapy — advanced/metastatic

Failure of first-line therapy

Cannot have received: fluorouracil

no use of fluorouracil ... in the first-line therapy

Cannot have received: irinotecan

no use of ... irinotecan ... in the first-line therapy

Cannot have received: liposomal irinotecan

no use of ... liposomal irinotecan drugs in the first-line therapy

Cannot have received: second-line or more anti-tumor therapy

Have received second-line or more anti-tumor therapy in the past

Lab requirements

Blood counts

Neutrophil count ≥ 1.5×10^9/L; Hemoglobin ≥ 10 g/dL; Platelet count ≥ 100×10^9/L

Kidney function

Creatinine clearance ≥ 60ml/min

Liver function

Total bilirubin ≤ 1.5× ULN; AST and ALT <1.5× ULN

Neutrophil count ≥ 1.5×10^9/L; Hemoglobin ≥ 10 g/dL; Platelet count ≥ 100×10^9/L; Total bilirubin ≤ 1.5× ULN; AST and ALT <1.5× ULN; Creatinine clearance ≥ 60ml/min

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06662006 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior fluorouracil, irinotecan, liposomal irinotecan disqualifies patients from enrollment.

What disease stage is eligible?

Stage IV is required (metastatic disease required).

Is there an age limit?

Yes. Patients must be 75 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.

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