Trial reportInvestigational new drugs2025
Efficacy and safety of multi-target tyrosine kinase inhibitor AL2846 combined with gemcitabine in pancreatic cancer.
Trial report in Investigational new drugs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06278493 (A Phase I/IIa Clinical Trial AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer.), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I/IIa Clinical Trial AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer.
Who cites it
1 citing paper in PubMed.
- Breaking Through the Limits: Nanomedicine at the Service of New Drug Combinations to Tackle Pancreatic Cancer.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
Pancreatic cancer patients urgently need new treatments, and we explored the efficacy and safety of combination therapy with AL2846 and gemcitabine in pancreatic cancer patients. This was a single-arm, single-center, open-label phase I/IIa study (NCT06278493). The dose-escalation phase was designed to evaluate the maximum tolerated dose (MTD) of AL2846 combined with gemcitabine. One or two dose levels were chosen for the dose-expansion phase. Treatment continued until disease progression, intolerable toxicity, patient withdrawal, or at the investigators' discretion. The primary study endpoint is to evaluate the safety and MTD of AL2846 combined with gemcitabine. The secondary endpoints included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and disease control rate (DCR). Between August 2018 and July 2021, 33 pancreatic cancer patients were enrolled in the study. A total of 15 patients were enrolled in the dose-escalation phase, and the MTD was not determined. Eventually 90 mg and 120 mg of AL2846 were chosen for the dose-expansion phase, in which 11 patients (90 mg) and 7 patients (120 mg) were administered. Treatment-related adverse events (TRAEs) of any grade were reported in 30 (90.91%) patients, and those of grade ≥ 3 were reported in 16 (48.48%) patients. The most frequently reported grade ≥ 3 TRAEs were thrombocytopenia (18.18%), neutropenia (12.12%), elevated γ-glutamyltransferase (6.06%), proteinuria (6.06%), and gastrointestinal hemorrhage (6.06%).The ORR was 6.06%, and the DCR was 72.73%. The median PFS was 3.71 months (95% CI: 3.38-4.11), and the median OS was 5.59 months (95% CI: 4.11-8.71). Gemcitabine and Al2846 combination therapy exhibited tolerable safety, but there was no improvement in efficacy over standard treatment. Further evaluation of this approach is still needed.
Indexed as
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.