Tumor microenvironment phenotyping guides precision therapy in unresectable pancreatic cancer

Table 1 Summarizes the key clinical trials of gemcitabine/nab-paclitaxel treatment, and the transition from monotherapy to combination therapy

Therapeutic regimen	Trial (phase)	Ref.	Nation/state	Year	Study population	Median OS (months)	ORR (%)	PFS (months)	Key biomarkers	Grade ≥ 3 toxicity	Trial ID
Gemcitabine monotherapy		Burris et al[105]	United States	1997	20	NR	NR	NR	NR	NR	NR
Gemcitabine monotherapy		Hartlapp et al[45]	Germany	2008	319	NR	NR	NR	NR	NR	NR
Nab-paclitaxel monotherapy	Phase I	Rajeshkumar et al[8]	United States	2011	20	NR	NR	NR	NR	NR	NR
AG	MPACT (phase III)	Goldstein et al[14]; Von Hoff et al[15]	Multi-country	2013	861	8.7	23	NR	SPARC: PFS + 3.2 months	Neutropenia 38%	NCT00844649
AG	LAPACT	Philip et al[74]	Multi-country	2020	106	NR	NR	NR	NR	NR	NCT02301143
AG	JCOG1611-GENERATE	Ohba et al[62]	Japan	2023	246	17.0	58	NR	KRAS WT: ORR 58% vs 32%	Diarrhea 5%	JCOG1611
AG + PEGPH20	TARGET-LAPC (phase II)	Hingorani et al[80]	Multi-country	2018	246	11.5	34	NR	HA: ORR + 22%	Edema 18%	NCT01839487
AG + toripalimab	Phase Ib/II	Chang et al[73]	China	2021	NR	16.3	41.7	NR	CD8+ core density > 10%	Colitis 12%	NCT04132531

AG: Gemcitabine plus nab-paclitaxel; PEGPH20: Pegylated recombinant human hyaluronidase PH20; MPACT: Metastatic pancreatic adenocarcinoma clinical trial; LAPC: Locally advanced unresectable pancreatic cancer; OS: Overall survival; ORR: Objective response rate; PFS: Progression-free survival; SPARC: Secreted protein acidic and rich in cysteine; WT: Wild type; HA: Hyaluronan; CD: Cluster of differentiation; NCT: National clinical trials; NR: Not reported.