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Table 1 Ongoing phase 3 clinical trials of combined immunotherapy in gastrointestinal cancers

From: Combination regimens with PD-1/PD-L1 immune checkpoint inhibitors for gastrointestinal malignancies

Tumor type Phase/participants Immune checkpoint inhibitors classification Combination intervention Status ClinicalTrials.gov identifier
Unresectable, recurrent, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma 3/371 PD-L1 inhibitors Avelumab + BSC VS physician’s choice + BSC Active, not recruiting NCT02625623
Various advanced cancers 3/939 PD-1 and CTLA-4 inhibitors Nivolumab + ipilimumab or nivolumab + fluorouracil + cisplatin VS fluorouracil + cisplatin Recruiting NCT03143153
Esophageal neoplasms 3/700 PD-1 inhibitors Pembrolizumab + cisplatin and 5-fluorouracil (5-FU) VS placebo + cisplatin and 5-FU Recruiting NCT03189719
Esophageal carcinoma| esophagogastric junction carcinoma 3/720 PD-1 inhibitors Pembrolizumab (MK-3475) VS Investigator’s Choice Standard Therapy Active, not recruiting NCT02564263
Gastric cancer 3/700 PD-1 inhibitors Nivolumab + S-1 therapy or CapeOX therapy VS placebo+ S-1 therapy or CapeOX therapy Recruiting NCT03006705
Gastric cancer 2,3/680 PD-1 inhibitors ONO-4538 + chemotherapy Active, not recruiting NCT02746796
Gastric cancer| gastroesophageal junction cancer 3/1649 PD-1 and CTLA-4 inhibitors Nivolumab + ipilimumab or nivolumab + chemotherapy VS chemotherapy alone Recruiting NCT02872116
Gastric cancer| Gastroesophageal junction cancer 3/860 PD-1 inhibitors Pembrolizumab (MK-3475) + chemotherapy VS placebo + chemotherapy Recruiting NCT03221426
Stomach neoplasms 3/780 PD-1 inhibitors Pembrolizumab (MK-3475) + chemotherapy VS placebo + chemotherapy Not yet recruiting NCT03675737
Gastric neoplasms| gastroesophageal junction adenocarcinoma 3/732 PD-1 inhibitors Pembrolizumab/Placebo + trastuzumab + Chemotherapy Recruiting NCT03615326
Gastric adenocarcinoma 3/764 PD-1 inhibitors Pembrolizumab as monotherapy, or pembrolizumab + Cisplatin + 5-fluorouracil (5-FU) or capecitabine; placebo + cisplatin + 5-FU or capecitabine Active, not recruiting NCT02494583
Biliary tract neoplasms 3/390 PD-1 inhibitors KN035 + gemcitabine + oxaliplatin VS gemcitabine + oxaliplatin Recruiting NCT03478488
Hepatocellular carcinoma 3/330 PD-1 inhibitors Pembrolizumab (MK-3475) or placebo + Best supportive care Recruiting NCT03062358
Hepatocellular Carcinoma 3/480 PD-L1 inhibitors Atezolizumab + bevacizumab VS sorafenib Recruiting NCT03434379
Hepatocellular carcinoma 3/1200 PD-L1 and CTLA-4 inhibitors Durvalumab + tremelimumab Recruiting NCT03298451
Pancreatic cancer stage IV 2/40 PD-1 inhibitors Nivolumab + cabiralizumab + gemcitabine VS gemcitabine Not yet recruiting NCT03697564
Colorectal cancer 3/363 PD-L1 inhibitors Cobimetinib + atezolizumab and atezolizumab monotherapy VS regorafenib Active, not recruiting NCT02788279
Colorectal adenocarcinoma| mismatch repair deficiency 3/347 PD-L1 inhibitors Atezolizumab, bevacizumab, Mfolfox6 VS bevacizumab, Mfolfox6 VS atezolizumab Recruiting NCT02997228
Colon Adenocarcinoma| DNA repair disorder 3/700 PD-L1 and CTLA-4 inhibitors Combination chemotherapy with or without atezolizumab Recruiting NCT02912559
Colorectal cancer 3/180 PD-1 inhibitors Nivolumab with standard of care therapy VS standard of care therapy for first-line treatment Recruiting NCT03414983