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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