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. 2025 Oct 13;16:1680838. doi: 10.3389/fimmu.2025.1680838

Table 9.

Clinical studies in esophageal squamous cell carcinoma.

Patient group Treatment Participants (n) Trial, ID Outcomes Reference
Advanced ESCC Nivolumab + ipilimumab 325 Phase 3, NCT03143153 (CheckMate 648) ORR in PD-L1 positive: 35%
ORR overall: 28%
Median OS in PD-L1 positive: 13.7 months
Median OS overall: 12.7 months
12-month OS rate in PD-L1 positive: 57%
Median PFS in PD-L1 positive: 4.0 months
Median PFS overall: Not tested
Grade 3–4 AEs: 32%
Doki et al., 2022 (136)
Advanced ESCC Durvalumab + tremelimumab 59 Phase 1, NCT01938612 ORR overall: 20.3%
ORR in PD‐L1 TC ≥ 25%: 50%
ORR in PD‐L1 TC < 25%: 12.2%
ORR in PD-L1 TC ≥ 1%: 24.2%
ORR in PD-L1 TC < 1%: 6.3%
Median PFS: 2.9 months
Median OS: 7.9 months
12-month OS rate: 35.3%
Grade ≥ 3 AE: 13.6%
Doki et al., 2022 (137)

AE, adverse event; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; TC, tumor cells.