Table 3.
Main Ongoing Clinical Trials
| Title | Identifier | Phase | Line | Intervention | Sample size | Primary ending points |
|---|---|---|---|---|---|---|
| HCC | ||||||
| TACE Combined with Anti-PD-1 Antibody in Patients with Advanced Hepatocellular Carcinoma | NCT04297280 | II | 1st Line | IBI308 plus TACE | 25 | ORR |
| Neoadjuvant Therapy for Hepatocellular Carcinoma | NCT04174781 | II | Neoadjuvant | IBI308 plus TACE | 61 | PFS |
| Ib Study of the Efficacy and Safety of IBI310 Combined with Sintilimab in Advanced Hepatocellular Carcinoma | NCT04401813 | Ib | 2nd Line | IBI308 plus IBI310 | 47 | AE&ORR |
| A Study to Evaluate the Efficacy and Safety of Sintilimab in Combination with IBI305 (Anti-VEGFR Monoclonal Antibody) Compared to Sorafenib as The First-Line Treatment for Advanced Hepatocellular Carcinoma | NCT03794440 | II/III | 1st Line | IBI308 plus IBI305 VS sorafenib | 566 | OS& PFS |
| Combination of Sintilimab and Stereotactic Body Radiotherapy in Hepatocellular Carcinoma (ISBRT01) | NCT04167293 | II/III | 2nd Line | SBRT plus IBI308 VS SBRT | 116 | PFS |
| Anlotinib Hydrochloride Capsules Combined with Sintilimab Injection in the Treatment of Advanced Hepatocellular Carcinoma (HCC) | NCT04052152 | II | 1st Line | Anlotinib plus IBI308 | 20 | ORR & ARR |
| A Study of Sintilimab Combined with Apatinib and Capecitabine in Advanced Hepatocellular Carcinoma | NCT04411706 | II | 1st Line | IBI308 plus apatinib plus capecitabine | 46 | ORR |
| Safety and Efficacy of Radiotherapy Plus Sintilimab for HCC with Portal Vein Tumor Thrombosis | NCT04104074 | I | NA | IBI308 plus radiotherapy | 20 | AEs |
| Safety and Efficacy Study of Sintilimab Combined with IBI305 in Patients with Advanced Hepatocellular Carcinoma | NCT04072679 | I | 1st Line | IBI308 plus IBI305 | 45 | AEs |
| Microwave Locoregional Treatment with Immunotherapy for Unresectable HCC | NCT04220944 | I | 1st Line | IBI308 plus TACE plus Microwave Ablation | 45 | PFS |
| TAI Combined with PD-1 Inhibitor in Locally Advanced, Potentially Resectable HCC | NCT03869034 | II | 1st Line | TAI(FOLFOX) plus IBI308 | 40 | PFS |
| Pediatric Tumors | ||||||
| Sintilimab in the Treatment of Advanced and Refractory Pediatric Malignant Tumors | NCT04400851 | I | NA | IBI308 | 18 | MTD |
| NSCLC | ||||||
| Sintilimab Combined with Bevacizumab for Brain Metastases from Non-small Cell Lung Cancer | NCT04213170 | II | 1st Line | IBI308 plus Bevacizumab | 60 | iORR |
| Anlotinib Plus Sintilimab for NSCLC Patients with First-generation EGFR-TKIs Drug Resistance Along with T790M Negative | NCT03765775 | II | NA | IBI308 plus anlotinib | 20 | PFS |
| Sintilimab Combined with Docetaxel for Standard Chemotherapy Failure Non-driver Gene Mutation Metastatic Non-small Cell Lung Cancer | NCT04144582 | II | 2nd Line | IBI308 plus Docetaxel | 30 | ORR |
| Consolidation Sintilimab After Concurrent Chemoradiation in Patients with Unresectable Stage III NSCLC | NCT03884192 | II | 1st Line | IBI308 plus Docetaxel | 30 | ORR |
| Safety and Tolerability Evaluation of Sintilimab in Combination with Radiation in Stage IV NSCLC Patients | NCT03812549 | I | 1st Line | SBRT plus IBI308 | 29 | AEs |
| Efficacy and Safety of Sintilimab With or Without Radiotherapy in Patients with Recurrent or IV NSCLC (EGFR -, ALK -) After Failure of Platinum-based Chemotherapy: A Randomized, Open Labled, Phase II Clinical Study | NCT04513301 | II | NA | IBI308 alone or IBI308 plus Radiotherapy | 70 | ORR & AEs |
| SCLC | ||||||
| Assessing Safety and Efficacy of Sintilimab and Metformin Combination Therapy in SCLC | NCT03994744 | II | NA | IBI308 plus Metformin | 68 | ORR & Safety |
| Anlotinib Combined with Sintilimab as Second-line Treatment or Beyond in Patients With Small Cell Lung Cancer | NCT04192682 | II/III | 2nd Line | IBI308 plus anlotinib | 40 | PFS |
| The Efficacy of PD-1 Antibody Sintilimab on Early-stage Multiple Primary Lung Cancer With Ground Glass Density. | NCT04026841 | II | 1st Line | IBI308 | 36 | ORR |
| Colorectal Cancer | ||||||
| Anlotinib Plus Sintilimab as First-line Treatment for Patients with Advanced Colorectal Cancer (APICAL-CR) | NCT04271813 | II | 1st Line | IBI308 plus anlotinib | 30 | ORR |
| Phase II Study to Evaluate the Efficacy and Safety of Fruquintinib Plus Sintilimab as Third-line Therapy for Colorectal Cancer | NCT04179084 | II | 3rd Line | IBI308 plus fruquintinib | 30 | ORR |
| IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient(dMMR)/Microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer | NCT04258111 | II | NA | IBI308 plus IBI310 | 68 | ORR |
| Esophageal Cancer | ||||||
| Sintilimab in Combination with Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer | NCT03946969 | I/II | Neoadjuvant | IBI308 plus Chemo | 40 | AEs |
| Sintilimab Plus Chemotherapy Followed by dCRT in Locally Advanced ESCC | NCT03985046 | I | NA | IBI308 plus Chemo | 25 | LCR |
| Gastric Cancer | ||||||
| Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination with XELOX as First Line Treatment in Patients with Gastric Cancer | NCT03745170 | III | 1st Line | IBI308 or Placebo plus Chemo | 650 | OS |
| The Purpose of This Study is to Evaluate the Efficacy and Safety of Sintilimab in Combination with Xelox as Neoadjuvant Therapy for Patients with Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcinoma. | NCT04065282 | II | Neoadjuvant | IBI308 plus Xelox | 36 | pCR |
| Cervical Cancer | ||||||
| Combination of PD-1 Monoclonal Antibody and HPV Vaccine in Patients with Cervical Cancer | NCT04096911 | II | 2nd Line | IBI308 plus quadrivalent HPV vaccine | 20 | ORR |
| Ovarian Cancer | ||||||
| An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients with Relapsed/Refractory Ovarian Cancer | NCT03989336 | I/II | ≥3rd Line | IBI308 plus Chemo plus Manganese Chloride | 80 | ORR & AEs |
| ICC | ||||||
| Systemic Chemotherapy Plus PD-1 for Metastasis ICC | NCT04398927 | II | 1st Line | IBI308 plus FOLFIRI | 25 | PFSR |
| Biliary Tract Cancer | ||||||
| Anlotinib in Combination with PD1 With Gemcitabine Plus (+) Cisplatin for Unresectable or Metastatic Biliary Tract Cancer | NCT04300959 | II | 1st Line | IBI308 plus anlotinib plus Chemo | 80 | 12 m-OS rate |
| Lymphoma | ||||||
| Sintilimab with P-GemOx Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type | NCT04127227 | II | 1st Line | IBI308 plus pegaspargase plus chemo | 63 | ORR & complete remission rate |
| Sintilimab (IBI308) in Refractory or Relapsed PMBCL, PT/NKCL and PCNSL | NCT04052659 | II | ≥3rd Line | IBI308 | 30 | ORR |
| Nasopharyngeal Carcinoma | ||||||
| Sintilimab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma | NCT03700476 | III | NA | IBI308 plus Chemo | 420 | FFS |
| Soft Tissue Sarcoma | ||||||
| The Combination of Sintilimab and AI (Doxorubicin, ADM/Ifosfamide, IFO) for the First Line Treatment of Select Type of Metastatic/Unresectable Soft Tissue Sarcoma | NCT04356872 | II | 1st Line | IBI308 plus Doxorubicin Hydrochloride plus Ifosfamide | 45 | ORR |
TACE transarterial chemoembolization, ORR objective response rate, iORR intracranial objective response rate, OS overall survival, PFS progression-free survival, PFSR progression free survival rate, AE adverse event, ARR adverse reaction rate, AER incicende of adverse events, TAI transarterial infusion chemotherapy, MTD maximum tolerable dose, SBRT stereotactic body radiation therapy, LCR local control rate, pCR pathological complete response rate, FFS failure-free survival, NA not applicable