Table 3.
Ongoing phase III clinical trials on immune checkpoint inhibitors for gastrointestinal cancers.
| Tumor type | Treatment | ClinicalTrials.gov identifier | Patient feature |
|---|---|---|---|
| Esophageal cancer | Nivolumab versus Docetaxel/Paclitaxel | NCT02569242 | Histologically confirmed unresectable advanced or recurrent
EC Refractory to or intolerant of standard therapy |
| Nivolumab + Ipilimumab or Nivolumab combined with fluorouracil + cisplatin versus fluorouracil + cisplatin | CheckMate 648 (NCT03143153) |
Unresectable advanced, recurrent or metastatic previously untreated ESCC | |
| Pembrolizumab + cisplatin and 5-fluorouracil (5-FU) versus placebo + cisplatin and 5-FU | KEYNOTE-590 (NCT03189719) |
First-line treatment in patients with locally advanced or metastatic esophageal carcinoma | |
| Pembrolizumab versus placebo | KEYNOTE-975 (NCT04210115) |
Patients with esophageal carcinoma who are receiving chemotherapy and radiation therapy | |
| SHR-1210 (camrelizumab) versus
Investigator’s choice standard therapy (Docetaxel or Irinotecan) |
NCT03099382 | Histologically or cytologically confirmed ESCC, locally
advanced, unresectable, recurrent or metastatic
disease Fail to the first-line standard therapy |
|
| SHR-1210 + paclitaxel + cisplatin versus
placebo + paclitaxel + cisplatin |
NCT03691090 | Histologically or cytologically confirmed unresectable local
advanced/recurrent or metastasis ESCC; No previous systemic anti-tumor treatment |
|
| Gastric and Gastroesophageal junction cancer | Nivolumab +S-1 or CapeOX, in comparison with placebo + S-1 or CapeOX | NCT03006705 | Patients with pStage III GC (including GEJc) after D2 or more extensive lymph node dissection (postoperative adjuvant chemotherapy) |
| Nivolumab + Ipilimumab or Nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine | NCT02872116 | Patients with previously untreated advanced or metastatic GC or GEJc | |
| Nivolumab + SOX/CapeOX versus placebo + SOX/CapeOX | ATTRACTION-4 (NCT02746796) |
Patients with unresectable advanced or recurrent GC (including GEJc) that has not been treated with the first-line therapy with systemic antitumor agents | |
| Pembrolizumab versus Paclitaxel | KEYNOTE-063 (NCT03019588) | Asian patients with advanced GC or GEJc who progressed after first-line therapy with platinum and fluoropyrimidine | |
| Pembrolizumab (MK-3475) + Chemotherapy (XP or FP) versus placebo + chemotherapy (XP or FP) | KEYNOTE-585 (NCT03221426) | Neoadjuvant/Adjuvant treatment for patients with GC or GEJc | |
| Pembrolizumab + trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy | KEYNOTE-811 (NCT03615326) |
Patients with HER2 positive advanced GC or GEJc | |
| Pembrolizumab + chemotherapy (FP or CAPOX regimens) versus placebo + chemotherapy (FP or CAPOX regimens) | KEYNOTE-859 (NCT03675737) | Patients with HER2 negative, previously untreated, unresectable or metastatic GC or GEJc | |
| Colorectal cancer | Nivolumab in combination with standard of care chemotherapy with bevacizumab | CheckMate 9X8 (NCT03414983) | First-line treatment of patients with mCRC |
| Nivolumab alone, Nivolumab in combination with Ipilimumab, or an investigator’s choice chemotherapy | CheckMate 8HW (NCT04008030) | Patients with MSI-H or dMMR mCRC | |
| mFOLFOX6/Bevacizumab combination chemotherapy with or without Atezolizumab or Atezolizumab monotherapy | COMMIT Study (NCT02997228) | First-line treatment of patients with dMMR mCRC | |
| Hepatocellular carcinoma | Durvalumab + Tremelimumab combination therapy and Durvalumab monotherapy versus Sorafenib | HIMALAYA (NCT03298451) | Patients with no prior systemic therapy for unresectable HCC |
| Transarterial chemoembolization (TACE) in combination with durvalumab monotherapy or TACE given with durvalumab + bevacizumab therapy compared with TACE alone | EMERALD-1 (NCT03778957) | Patients with locoregional HCC not amenable to curative therapy | |
| Durvalumab in combination with bevacizumab or durvalumab monotherapy or placebo as adjuvant therapy | EMERALD-2 (NCT03847428) |
Patients with HCC who are at high risk of recurrence after curative hepatic resection or ablation | |
| CS1003 (anti-PD-1 mAb) in combination with lenvatinib and placebo in combination with lenvatinib | NCT04194775 | Patients with no prior systemic treatment and with unresectable HCC | |
| Nivolumab + Ipilimumab versus standard of care (sorafenib or lenvatinib) | CheckMate 9DW (NCT04039607) | Patients with advanced HCC who have not received prior systemic therapy | |
| Adjuvant nivolumab versus placebo | CheckMate 9DX (NCT03383458) | Patients with HCC who are at high risk of recurrence after curative hepatic resection or ablation | |
| Pembrolizumab or placebo given with best supportive care in Asian patients | KEYNOTE-394 (NCT03062358) |
Asian patients with previously systemically treated advanced HCC | |
| Pembrolizumab versus placebo as adjuvant therapy | KEYNOTE-937 (NCT03867084) | Adjuvant therapy in patients with HCC and complete radiological response after surgical resection or local ablation | |
| Lenvatinib in combination with pembrolizumab versus Lenvatinib in combination with placebo | LEAP-002 (NCT03713593) |
First-line therapy of participants with advanced HCC | |
| Cabozantinib in combination with atezolizumab versus the standard of care sorafenib | COSMIC-312 (NCT03755791) |
Patients with advanced HCC who have not received previous systemic anticancer therapy | |
| Adjuvant therapy with atezolizumab + bevacizumab compared with active surveillance | IMbrave050 (NCT04102098) |
Patients with completely resected or ablated HCC who are at high risk for disease recurrence | |
| Biliary tract cancers | Durvalumab in combination with gemcitabine + cisplatin versus placebo in combination with gemcitabine + cisplatin | TOPAZ-1 (NCT03875235) | Patients with first-line advanced BTC |
| KN035 (anti-PD-L1 antibody) compared with standard of care gemcitabine-based chemotherapies | KN035-BTC (NCT03478488) |
Patients with previously untreated locally advanced or metastatic BTC | |
| Pembrolizumab + gemcitabine/cisplatin versus placebo + gemcitabine/cisplatin as first-line therapy | KEYNOTE-966 (NCT04003636) |
Patients with advanced and/or unresectable BTC |
BTC, biliary tract cancer; CapeOX, capecitabine plus oxaliplatin; CAPOX, oxaliplatin combined with capecitabine; dMMR, mismatch repair deficient; EC, esophageal cancer; ESCC, esophageal squamous cell carcinoma; FP, Cisplatin combined with 5-Fluorouracil; GC, gastric cancer; GEJc, gastroesophageal junction cancer; HCC, hepatocellular carcinoma; HER2, human epidermal growth factor receptor 2; mCRC, metastatic colorectal cancer; mFOLFOX6, modified oxaliplatin plus leucovorin plus 5-fluorouracil; MSI-H, microsatellite instability-high; PD-1, programmed cell death 1; PD-L1, programmed cell death ligand 1; S-1, tegafur-gimeracil-oteracil potassium; SOX, S-1 plus oxaliplatin; XP, capecitabine plus cisplatin.