RecruitingPhase 2

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

China56 participantsStarted 2024-03-01

Plain-language summary

This 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years and ≤ 75 years, ECOG score of ≤2 points, expected survival time ≥ 3 months.
✓. Patients with histologically or cytologically confirmed advanced metastatic pancreatic cancer.
✓. Imaging suggests distant measurable lesions.
✓. Failure of first-line therapy and no use of fluorouracil, irinotecan, or liposomal irinotecan drugs in the first-line therapy.

Exclusion criteria

✕. Have received second-line or more anti-tumor therapy in the past.
✕. First-line treatment with fluorouracil, irinotecan or liposomal irinotecan, etc.
✕. Patient has a prior history of other tumors, unless it is cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumors (Ta and TIS) or other malignancies that have received curative therapy (at least more than 5 years prior to enrollment).
✕. Patient has an active bacterial or fungal infection (≥ 3rd edition NCI-CTC2 grade).

What they're measuring

Objective effective rate (ORR)

Timeframe: 28 days per cycle, with ≤6 cycles of treatment expected per patient

Trial details

NCT IDNCT06662006

SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Juan Du, M.D. Ph.D

+86-025-83106666 dujunglyy@163.com

View on ClinicalTrials.gov More Advanced Metastatic Pancreatic Cancer trials