Across 97 unique European CTIS pancreatic cancer Phase II/III-containing trials, endpoint selection is dominated by safety/adverse events in 80 trials (82.5%), overall survival or mortality in 71 trials (73.2%), and progression-free survival in 66 trials (68.0%). Primary endpoints most often emphasize safety (38/97, 39.2%) and objective response rate (24/97, 24.7%), while secondary endpoints carry most of the survival, response, quality-of-life, biomarker, and pharmacokinetic burden.
Safety/adverse events appeared in 80 of 97 trials (82.5%), followed by overall survival or mortality in 71 (73.2%) and progression-free survival in 66 (68.0%). Response-based endpoints remained common but less universal: objective response rate appeared in 52 trials (53.6%), disease control in 43 (44.3%), and duration of response in 39 (40.2%).
European pancreatic cancer CTIS submissions use a broad endpoint stack: safety is nearly universal, survival is the dominant confirmatory outcome family, and response endpoints remain central for signal-seeking and expansion designs.
Primary endpoints were present in 90 of 97 trials (92.8%), secondary endpoints in 84 (86.6%), and structured other/exploratory endpoints in 4 (4.1%). Across 740 endpoint items, 164 were primary (22.2%), 567 were secondary (76.6%), and 9 were other/exploratory (1.2%).
| Endpoint category | Primary | Secondary | Other / exploratory |
|---|---|---|---|
| Safety / adverse events | 38 / 97 (39.2%) | 60 / 97 (61.9%) | 0 / 97 (0.0%) |
| Objective response rate | 24 / 97 (24.7%) | 40 / 97 (41.2%) | 1 / 97 (1.0%) |
| Overall survival / mortality | 16 / 97 (16.5%) | 60 / 97 (61.9%) | 1 / 97 (1.0%) |
| Progression-free survival | 16 / 97 (16.5%) | 57 / 97 (58.8%) | 2 / 97 (2.1%) |
| Disease control / stable disease | 11 / 97 (11.3%) | 39 / 97 (40.2%) | 1 / 97 (1.0%) |
| Duration of response | 1 / 97 (1.0%) | 39 / 97 (40.2%) | 0 / 97 (0.0%) |
| Quality of life / PRO | 0 / 97 (0.0%) | 34 / 97 (35.1%) | 0 / 97 (0.0%) |
| Biomarker / MRD / immune response | 4 / 97 (4.1%) | 32 / 97 (33.0%) | 3 / 97 (3.1%) |
| Pharmacokinetics | 3 / 97 (3.1%) | 29 / 97 (29.9%) | 0 / 97 (0.0%) |
| Surgery / pathology endpoints | 10 / 97 (10.3%) | 20 / 97 (20.6%) | 1 / 97 (1.0%) |
The primary endpoint layer is narrower and decision-oriented, led by safety and ORR. The secondary layer is where pancreatic cancer protocols preserve the full evidence package: OS, PFS, response depth, QoL, biomarkers, and PK.
Using exclusive phase groups, the cohort includes 66 Phase II-only trials (68.0%), 22 Phase III-only trials (22.7%), and 9 Phase II/III trials (9.3%). In Phase II-only trials, safety appeared in 62 of 66 (93.9%), PFS in 54 (81.8%), and ORR in 44 (66.7%). In Phase III-only trials, OS led with 14 of 22 trials (63.6%).
| Endpoint category | Phase II only n=66 |
Phase III only n=22 |
Phase II/III n=9 |
|---|---|---|---|
| Safety / adverse events | 62 (93.9%) | 13 (59.1%) | 5 (55.6%) |
| Overall survival / mortality | 51 (77.3%) | 14 (63.6%) | 6 (66.7%) |
| Progression-free survival | 54 (81.8%) | 8 (36.4%) | 4 (44.4%) |
| Objective response rate | 44 (66.7%) | 5 (22.7%) | 3 (33.3%) |
| Disease control / stable disease | 37 (56.1%) | 4 (18.2%) | 2 (22.2%) |
| Duration of response | 35 (53.0%) | 3 (13.6%) | 1 (11.1%) |
| Quality of life / PRO | 24 (36.4%) | 5 (22.7%) | 5 (55.6%) |
| Biomarker / MRD / immune response | 29 (43.9%) | 3 (13.6%) | 2 (22.2%) |
The phase signal is clear: Phase II pancreatic cancer trials retain exploratory oncology me