Table 3 The list of FDA approval of ICIs in different GI cancers
From: Immune checkpoint inhibitors in gastrointestinal malignancies: an Umbrella review
NCT | Trial name | Trial design | Standard arm | Line | Treatment | OS (Months) | PFS (Months) | PDL1 Status | ||
|---|---|---|---|---|---|---|---|---|---|---|
Name of drug | Type of drug | Mode | ||||||||
HCC | ||||||||||
NCT03434379 | IMbrave-150 | Open label randomized phase III | Sorafenib | First | Atezolizumab + Bevacizumab | Anti-PD-L1 + Anti-VEGF | Combination | Not est. vs 13.2 | 6.8 vs 4.3 | No |
NCT02702414 | Keynote-244 | Open label, non-randomized phase II | None | Second | Pembrolizumab | Anti-PD1 | Monotherapy | 13.2 | 4.9 | No |
NCT01658878 | Checkmate-040 | Open label, non-comparative, dose escalation and expansion phase I/II | None | Second | Nivolumab | Anti-PD1 | Monotherapy | 83% at 6; 74% at 9 | 37% at 6; 28% at 9 | No |
NCT01658878 | Checkmate-040 | Open label, non-comparative, dose escalation and expansion Phase I/II | None | Second | Nivolumab + Ipilimumab | Anti-PD1 + Anti- CTLA4 | Combination | 22.8 |  | No |
GC | ||||||||||
NCT02872116 | Checkmate-649 | Open label randomized phase III | Capecitabine and Oxaliplatin | First | Nivolumab + capecitabine + oxaliplatin | Anti-PD1 + chemotherapy | Combination | 13.1 vs 11.1 | 7·7 vs 6.05 | No |
NCT02335411 | Keynote-059 | Open label single arm phase II | None | Third | Pembrolizumab | Anti-PD1 | Monotherapy | 5.6 | 2 | CPS > 1 |
NCT02267343 | Attraction-2 | Double-blind randomized phase III | Placebo | Third | Nivolumab | Anti-PD1 | Monotherapy | 5·26 vs 4·14 | 1·61 vs 1.45 | No |
NCT01928394 | Checkmate-032 | Open label phase I/II |  | Third | Nivolumab + Ipilimumab | Anti-PD1 + Anti- CTLA4 | Combination | 6.9 | 1.4 | No |
EC | ||||||||||
NCT03189719 | Keynote-590 | Double-blind randomized phase III | 5-fluorouracil and Cisplatin | First | Pembrolizumab + Cisplatin + Fluorouracil | Anti-PD1 + chemotherapy | Combination | 13.9 vs 8.8 | 7.5 vs 5.8 | CPS ≥ 10 |
NCT03143153 | Checkmate-648 | Open label randomized phase III | 5-fluorouracil and Cisplatin | First | Nivolumab + Ipilimumab | Anti-PD1 + Anti- CTLA4 | Combination | 13.7 vs. 9.1 | 4 vs 4.4 | TPS ≥ 1% |
NCT03143153 | Checkmate-648 | Open label randomized phase III | 5-fluorouracil and Cisplatin | First | Nivolumab + Cisplatin + Fluorouracil | Anti-PD1 + chemotherapy | Combination | 15.4 vs. 9.1 | 6.9 vs 4.4 | TPS ≥ 1% |
NCT02564263 | Keynote-181 | Open label randomized phase III | Paclitaxel, Docetaxel, and Irinotecan | Second | Pembrolizumab | Anti-PD1 | Monotherapy | 9.3 vs 6.7 | 2.6 vs 3 | CPS ≥ 10 |
NCT02559687 | Keynote-180 | Open label single arm phase II | None | Second | Pembrolizumab | Anti-PD1 | Monotherapy | 5.8 | 2 | CPS ≥ 10 |
NCT02569242 | Attraction-3 | Open label randomized phase III | Paclitaxel or Docetaxel | Second | Nivolumab | Anti-PD1 | Monotherapy | 10.9 vs 8.4 | 1.7 vs 3.4 | No |
CRC | ||||||||||
NCT02563002 | Keynote-177 | Randomized phase III | mFOLFOX6/ FOLFIRI + / − Bevacizumab or Cetuximab | First * | Pembrolizumab | Anti-PD1 | Monotherapy | Not achieved vs 36.7 | 16.5 vs 8.2 | No |
NCT02060188 | Checkmate-142 | Open label single arm Phase II | None | First * | Nivolumab | Anti-PD1 | Monotherapy | 73% at 12 | 50.4% at 12 | No |
NCT02060188 | Checkmate-142 | Open label single arm Phase II | None | First * | Nivolumab + Ipilimumab | Anti-PD1 + Anti- CTLA4 | Combination | 85% at 12 | 71% at 12 | No |
NCT02460198 | Keynote-164 | Open label single arm Phase II | None | Second * | Pembrolizumab | Anti-PD1 | Monotherapy | 31.4 | 2.3 | No |