Across 88 unique CTIS/EU Phase II–III gastric, gastroesophageal junction (GEJ), and esophageal cancer trial records authorized in 2024–2026, overall survival (OS) was the most frequently measured endpoint family, appearing in 67/88 trials (76.1%). Safety/tolerability followed in 65/88 (73.9%) and progression-free survival (PFS) in 60/88 (68.2%). Phase III trials were especially OS-centered at 23/25 (92.0%), while Phase II-containing trials were led by safety/tolerability at 44/58 (75.9%).
Overall survival (OS) appeared in 67/88 trials (76.1%), followed by safety/tolerability in 65/88 (73.9%) and progression-free survival (PFS) in 60/88 (68.2%). Objective response rate (ORR) was present in 48/88 (54.5%), making tumor-response measurement common but less universal than survival and safety.
European Phase II–III gastric/GEJ/esophageal cancer trials remain survival-anchored: OS and PFS form the core efficacy language, while safety/tolerability is nearly as common because combination regimens, ADCs, immune therapies, radiopharmaceuticals and surgical approaches all require explicit risk monitoring.
Secondary endpoints carried most of the measurement breadth: 455/621 endpoint entries (73.3%) were secondary, compared with 154/621 (24.8%) primary and 12/621 (1.9%) other/exploratory entries. OS was the most frequent primary endpoint family at 25/88 trials (28.4%), narrowly ahead of safety/tolerability and ORR at 24/88 each (27.3%).
| Endpoint family | Primary | Secondary | Exploratory/other |
|---|---|---|---|
| Overall survival (OS) | 25 / 28.4% | 57 / 64.8% | 1 / 1.1% |
| Safety / tolerability | 24 / 27.3% | 52 / 59.1% | 1 / 1.1% |
| Progression-free survival (PFS) | 21 / 23.9% | 51 / 58.0% | 2 / 2.3% |
| Objective response rate (ORR) | 24 / 27.3% | 40 / 45.5% | 2 / 2.3% |
| Duration of response (DoR) | 1 / 1.1% | 40 / 45.5% | 0 / 0.0% |
| Quality of life / PRO | 0 / 0.0% | 35 / 39.8% | 3 / 3.4% |
| Pharmacokinetics (PK) | 2 / 2.3% | 28 / 31.8% | 1 / 1.1% |
| Immunogenicity / ADA | 0 / 0.0% | 27 / 30.7% | 1 / 1.1% |
| Surgical / postoperative | 11 / 12.5% | 22 / 25.0% | 2 / 2.3% |
| Disease control rate (DCR) | 1 / 1.1% | 23 / 26.1% | 1 / 1.1% |
| Biomarker / translational | 5 / 5.7% | 9 / 10.2% | 4 / 4.5% |
Primary endpoints are concentrated around OS, ORR, safety and PFS. Secondary endpoints absorb the broader clinical package: DoR, QoL/PRO, PK, immunogenicity and DCR are mostly secondary rather than pivotal decision endpoints.
Phase II-containing trials numbered 58/88 (65.9%), Phase III trials 25/88 (28.4%), and mixed Phase II/III trials 5/88 (5.7%). Safety/tolerability was the most frequent Phase II-containing endpoint family at 44/58 (75.9%), while OS dominated Phase III at 23/25 (92.0%).
| Endpoint family | Phase II-containing n=58 | Phase III n=25 | Phase II/III n=5 |
|---|---|---|---|
| Overall survival (OS) | 41 / 70.7% | 23 / 92.0% | 3 / 60.0% |
| Safety / tolerability | 44 / 75.9% | 18 / 72.0% | 3 / 60.0% |
| Progression-free survival (PFS) | 39 / 67.2% | 19 / 76.0% | 2 / 40.0% |
| Objective response rate (ORR) | 32 / 55.2% | 14 / 56.0% | 2 / 40.0% |
| Quality of life / PRO | 19 / 32.8% | 17 / 68.0% | 1 / 20.0% |
| Pharmacokinetics (PK) | 18 / 31.0% | 11 / 44.0% | 1 / 20.0% |
| Diagnostic imaging / sensitivity-specificity | 7 / 12.1% | 0 / 0.0% | 2 / 40.0% |
The phase shift is clear: Phase II-containing trials emphasize safety, ORR and PFS as development and signal-finding measures, while Phase III trials move strongly toward OS and QoL/PRO, consistent with confirmatory benefit-risk and patient-impact packages.
Mixed gastric/GEJ plus esophageal cancer labels were the largest group at 45/88 trials (51.1%), followed by multi-tumor basket trials including gastric or esophageal cancer at 23/88 (26.1%). The mixed gastric/GEJ-esophageal group had high OS use at 40/45 (88.9%) and high PFS use at 34/45 (75.6%).
| Disease group | Overall survival (OS) | Safety/tolerability | Progression-free survival (PFS) | Objective response rate (ORR) | Quality of life/PRO | Surgical/postoperative | Diagnostic imaging/sensitivity-specificity |
|---|---|---|---|---|---|---|---|
| Mixed gastric/GEJ + esophageal n=45 | 40 / 88.9% | 32 / 71.1% | 34 / 75.6% | 30 / 66.7% | 22 / 48.9% | 14 / 31.1% | 0 / 0.0% |
| Multi-tumor basket incl. gastric/esophageal n=23 | 14 / 60.9% | 19 / 82.6% | 13 / 56.5% | 14 / 60.9% | 3 / 13.0% | 2 / 8.7% | 6 / 26.1% |
| Gastric / GEJ / gastroesophageal n=12 | 8 / 66.7% | 9 / 75.0% | 7 / 58.3% | 4 / 33.3% | 6 / 50. |