Table 4.
Selected ongoing randomized clinical trials investigating the efficacy of ICIs in GI cancer cases
| NCT number | Population under study | Therapies under comparison | Monotherapy/combination | Sample size (n) | ||
|---|---|---|---|---|---|---|
| HCC | ||||||
| NCT05277675 | Neoadjuvant therapy in the treatment of recurrent HCC | Tislelizumab/Sintilimab + Lenvatinib/Bevacizumab + radiofrequency ablation vs radiofrequency ablation | Combination | 160 | ||
| NCT04183088 | First-line therapy for advanced HCC | Tislelizumab + regorafenib vs regorafenib | Combination | 125 | ||
| NCT04658147 | - | Nivolumab + Relatlimab vs Nivolumab | Monotherapy vs Combination | 20 | ||
| NCT04233840 | - | Ropeginterferon alfa-2b + Nivolumab vs Nivolumab vs Ropeginterferon alfa-2b | Monotherapy vs Combination | 72 | ||
| NCT03383458 | HCC who has undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence | Nivolumab vs placebo | Monotherapy | 545 | ||
| NCT04050462 | - | Nivolumab vs Nivolumab + BMS-986253 vs Nivolumab + Cabiralizumab | Monotherapy vs Combination | 23 | ||
| NCT04567615 | - | Nivolumab and Relatlimab vs Nivolumab | Monotherapy vs Combination | 250 | ||
| NCT05039736 | - | Cabozantinib vs Nivolumab | Monotherapy | 30 | ||
| NCT04039607 | Advanced HCC | Nivolumab + Ipilimumab vs Sorafenib + lenvatinib | Combination | 732 | ||
| NCT02576509 | First- line treatment in patients with advanced HCC | Nivolumab vs Sorafenib | Monotherapy | 743 | ||
| NCT04340193 | Intermediate-stage HCC | Nivolumab + Ipilimumab + Trans-arterial ChemoEmbolizatio vs Nivolumab + Trans-arterial ChemoEmbolizatio vs Trans-arterial ChemoEmbolizatio | Combination | 26 | ||
| NCT04268888 | Intermediate-stage HCC | Transarterial Chemoembolisation and/or Transarterial Embolisation vs Transarterial Chemoembolisation and/or Transarterial Embolisation + Nivolumab | Combination | 552 | ||
| NCT05337137 | untreated advanced/metastatic HCC | Relatlimab + Nivolumab + Bevacizumab vs Nivolumab + Bevacizumab + Placebo | Combination | 162 | ||
| NCT04777851 | Intermediate-stage HCC | Regorafenib + Nivolumab vs Transarterial Chemoembolization | Combination | 496 | ||
| GC | ||||||
| NCT04294784 | Patients with advanced or recurrent GC and GEJ in second-line treatment | albumin-bound paclitaxel and SHR-1210 (PD-1 inhibitor) vs albumin-bound paclitaxel | Combination | 80 | ||
| NCT04997837 | D2/R0 resected pn3 GC or GEJ | Nivolumab/Toripalimab + Oxaliplatin + Capecitabine + Tegafur-gimeracil-oteracil potassium + 5-FU + RT vs Oxaliplatin + Capecitabine + Tegafur-gimeracil-oteracil potassium + 5-FU + RT | Combination | 433 | ||
| NCT04782791 | Nivolumab + oxaliplatin + Gastrectomy vs Nivolumab + Gastrectomy | Combination | 30 | |||
| NCT03443856 | Stage Ib-iva GC and GEJ and high risk of recurrence following neoadjuvant chemotherapy and resection | Nivolumab + Ipilimumab vs chemotherapy | Combination | 197 | ||
| NCT02935634 | Advanced GC | Nivolumab + Ipilimumab vs Nivolumab + Relatlimab vs Nivolumab + BMS-986205 vs Nivolumab + Rucaparib vs Ipilimumab + Rucaparib vs Nivolumab + Ipilimumab + Rucaparib | Combination | 190 | ||
| NCT02746796 | Unresectable advanced or recurrent GC and GEJ as the first-line therapy | Nivolumab + Oxaliplatin + Tegafur- Gimeracil-Oteracil potassium vs Nivolumab + Oxaliplatin + Capecitabine vs Nivolumab + Oxaliplatin + Tegafur- Gimeracil-Oteracil potassium + Capecitabine vs Oxaliplatin + Tegafur- Gimeracil-Oteracil potassium + Capecitabine + Placebo | Combination | 680 | ||
| NCT03006705 | In stage III GC and GEJ after D2 or more extensive lymph node dissection | Nivolumab + Oxaliplatin + Tegafur- Gimeracil-Oteracil potassium + Capecitabine vs Oxaliplatin + Tegafur- Gimeracil-Oteracil potassium + Capecitabine + Placebo | Combination | 800 | ||
| NCT05144854 | Chemotherapy-naïve participants with HER2-negative unresectable advanced or recurrent GC and GEJ | Nivolumab + Ipilimumab + Oxaliplatin + Capecitabine + S-1 vs Oxaliplatin + Capecitabine + S-1 | Combination | 600 | ||
| NCT03647969 | Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma | Nivolumab + Ipilimumab + mFOLFOX vs mFOLFOX vs Nivolumab + FLOT | Combination | 262 | ||
| NCT04062656 | GC and GEJ | Nivolumab + Oxaliplatin + Docetaxel + 5-FU + Folic acid vs Nivolumab + Oxaliplatin + Docetaxel + 5-FU + Folic acid + relatlimab | Combination | 21 | ||
| NCT02872116 | GC and GEJ | Nivolumab + Ipilimumab vs Oxaliplatin + Capecitabine vs Oxaliplatin + Leucovorin + Fluorouracil vs Nivolumab + Oxaliplatin + Capecitabine vs Oxaliplatin + Leucovorin + Fluorouracil + Nivolumab | Combination | 2031 | ||
| NCT04879368 | Gastro-esophageal cancer | Regorafenib + Nivolumab vs Docetaxel + Paclitaxel + Irinotecan + Trifluridine/Tipracil | Combination | 450 | ||
| NCT05568095 | locally advanced unresectable or metastatic GC, and GEJ and EC | Zimberelimab + Domvanalimab + Oxaliplatin + Leucovorin + Fluorouracil + Capecitabine vs Nivolumab Oxaliplatin + Leucovorin + Fluorouracil + Capecitabine | Combination | 970 | ||
| EC | ||||||
| NCT05182944 | - | Camrelizumab + Albumin Paclitaxel + Cisplatin + Camrelizumab vs Camrelizumab vs best supportive care | Monotherapy vs Combination | 130 | ||
| NCT05007145 | Resectable locally advanced thoracic EC | PD-1 inhibitor + Albumin-Bound Paclitaxel + Cisplatin vs Albumin-Bound Paclitaxel + Cisplatin + Radiation | Combination | 92 | ||
| NCT04785820 | Advanced or metastatic | RO7121661 vs RO7247669 vs Nivolumab | Monotherapy | 210 | ||
| NCT05213312 | Esophageal squamous cell carcinoma | Nivolumab + Cisplatin + Paclitaxel + 5Fluorouracil vs Cisplatin + Paclitaxel + 5Fluorouracil | Combination | 90 | ||
| NCT03604991 | Esophageal adenocarcinoma, Gastroesophageal junction adenocarcinoma | Carboplatin + Paclitaxel + RT vs Carboplatin + Nivolumab + Paclitaxel + RT vs Nivolumab vs Ipilimumab + Nivolumab | Monotherapy vs Combination | 514 | ||
| CRC | ||||||
| NCT03926338 | dMMR/MSI-H phenotype | Toripalimab + Celecoxib vs Toripalimab | Monotherapy vs Combination | 100 | ||
| NCT05141721 | Metastatic CRC | GRT-C901/GRT-R902 + Ipilimumab + Fluoropyrimidine + leucovorin + Bevacizumab + Atezolizumab vs Fluoropyrimidine + leucovorin + Bevacizumab | Combination | 665 | ||
| NCT04907539 | RNF43 or RSPO aberrated, MSS | RXC004 + Denosumab vs RXC004 + Denosumab + Nivolumab | Combination | 50 | ||
| NCT05308446 | Metastatic or unresectable BRAF-mutant | Cetuximab + Encorafenib vs Cetuximab + Encorafenib + Nivolumab | Combination | 84 | ||
| NCT03388190 | MSS/ pMMR phenotype | Oxaliplatin vs oxaliplatin + Nivolumab | Combination | 80 | ||
| NCT03414983 | Metastatic CRC | Oxaliplatin + Leucovorin + Fluorouracil + Bevacizumab vs Oxaliplatin + Leucovorin + Fluorouracil + Bevacizumab + Nivolumab | Combination | 195 | ||
| NCT04008030 | MSI-H/dMMR phenotype | Nivolumab vs Nivolumab + Ipilimumab vs Oxaliplatin + Leucovorin + Fluorouracil + Irinotecan + Bevacizumab + Cetuximab | Monotherapy vs Combination | 831 | ||
| NCT03803553 | Metastatic CRC | 5-Fluorouracil + Irinotecan + Leucovorin vs Nivolumab vs Encorafenib + Binimetinib + Cetuximab vs active surveillance | Monotherapy | 500 | ||
| NCT03377361 | - | Nivolumab + trametinib vs Nivolumab + Ipilimumab + trametinib vs Nivolumab + Ipilimumab + trametinib vs Nivolumab + Ipilimumab + trametinib vs Regorafenib vs Nivolumab + Ipilimumab + trametinib | Combination | 232 | ||
| NCT05328908 | Failed 1–4 prior lines of therapy | Nivolumab + Relatlimab vs Regorafenib or TAS-102 | Combination | 700 | ||
| PaC | ||||||
| NCT04612530 | - | Nivolumab vs Irreversible Electroporation (IRE) + Nivolumab vs IRE + Nivolumab + Toll-Like Receptor 9 | Monotherapy vs Combination | 18 | ||
| NCT04953962 | Stage IV | CBP501 (25) + Cisplatin + Nivolumab vs CBP501 (25) + Cisplatin vs Cisplatin + Nivolumab | Combination | 36 | ||
| NCT03563248 | Localized PaC | FOLFIRINOX + SBRT + surgery vs FOLFIRINOX + SBRT + surgery + Losartan vs FOLFIRINOX + SBRT + surgery + Losartan + Nivolumab vs FOLFIRINOX + SBRT + surgery + Nivolumab | Combination | 168 | ||
| NCT03336216 | Advanced PaC | Nab-paclitaxel + Onivyde + Fluorouracil + Gemcitabine + Leucovorin + irinotecan hydrochloride vs Cabiralizumab + Nivolumab vs Cabiralizumab + Nivolumab + Nab-paclitaxel + Gemcitabine vs Cabiralizumab + Nivolumab + Fluorouracil + Oxaliplatin + Leucovorin | Combination | 202 | ||
| NCT04229004 | Metastatic PaC | Gemcitabine + Nab-paclitaxel vs Oxaliplatin + Leucovorin + Irinotecan + 5-Fluorouracil vs amrevlumab + gemcitabine + nab-paclitaxel vs Canakinumab + Spartalizumab + nab-paclitaxel + gemcitabine vs SM-88 | Combination | 825 | ||
| NCT02451982 | Surgically resectable pancreatic ductal adenocarcinoma | Cyclophosphamide + GVAX vs Cyclophosphamide + GVAX + Nivolumab vs Cyclophosphamide + GVAX + Nivolumab + Urelumab vs Nivolumab + BMS-986253 | Combination | 76 | ||
| Different cancers | ||||||
| NCT03184870 | mCRC and mPaC | BMS-813160 + 5-fluorouracil + Leucovorin + Irinotecan vs BMS-813160 + Nab-paclitaxel + Gemcitabine vs BMS-813160 and Nivolumab | Combination | 332 | ||
| NCT03373188 | Stage I-III PaC, stage IV CRC | Surgery vs VX15/2503 + surgery vs VX15/2503 + Ipilimumab + surgery vs VX15/2503 + Nivolumab + surgery | Combination | 10 | ||
| NCT02866383 | Metastatic PaC and BTC | Nivolumab + Radiotherapy vs Nivolumab + Ipilimumab + Radiotherapy | Combination | 160 | ||
| NCT02743494 | Various advanced cancers | Nivolumab vs Placebo | Monotherapy | 794 | ||
| NCT03752398 | Solid tumors | XmAb®23104 vs XmAb®23104 + Ipilimumab | Combination | 234 | ||
HCC hepatocellular carcinoma, GC gastric cancer, EC: esophageal carcinoma, GEJ gastroesophgeal junction carcinoma, CRC colorectal cancer, PaC pancreatic cancer, dMMR miss match repair deficiency, pMMR proficient miss match repair, MSS microsatellite stable, MSI-H microsatellite instable-high, SBRT stereotactic body radiation therapy