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  • ||||||||||  Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, AiRuiKa (camrelizumab) / HLB Bio Group
    Retrospective data, Journal:  Oncological outcomes of sequential laparoscopic gastrectomy after treatment with camrelizumab combined with nab-paclitaxel plus S-1 for gastric cancer with serosal invasion. (Pubmed Central) -  Feb 13, 2024   
    The 2-year OS of C-SAP group (80.7%) was higher than that of SAP group (67.8%), and the difference was not statistically significant (P = 0.112); At 2 years after operation, the recurrence rate of C-SAP group (44.3%) was lower than that of SAP group (55.8%) (P = 0.097); Further analysis showed that the average time to recurrence in the C-SAP group was 18.9 months, which was longer than that in SAP group 13.1 months (P = 0.004); The 2-year recurrence free survival rate in C-SAP group was higher than that in SAP group (P=0.076); There was no significant difference in the overall survival time after recurrence between the two groups (P= 0.097). Camrelizumab combined with neoadjuvant chemotherapy can improve the proportion of ypT0, ypN0 and pCR in patients, while prolonging the initial recurrence time of patients in the C-SAP group, but did not increase the immunotherapy/chemotherapy related side effects and postoperative complications.
  • ||||||||||  AiRuiKa (camrelizumab) / HLB Bio Group
    Enrollment open, IO biomarker:  PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer (clinicaltrials.gov) -  Feb 7, 2024   
    P3,  N=436, Recruiting, 
    Camrelizumab combined with neoadjuvant chemotherapy can improve the proportion of ypT0, ypN0 and pCR in patients, while prolonging the initial recurrence time of patients in the C-SAP group, but did not increase the immunotherapy/chemotherapy related side effects and postoperative complications. Not yet recruiting --> Recruiting
  • ||||||||||  Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, AiRuiKa (camrelizumab) / HLB Bio Group
    Trial completion, Enrollment change, Trial completion date, Trial primary completion date:  The Conversion Therapy of Chemotherapy Plus Camrelizumab in Metastatic Gastric Cancer (clinicaltrials.gov) -  Feb 7, 2024   
    P2,  N=37, Completed, 
    Sponsored by: Elevar Recruiting --> Completed | N=60 --> 37 | Trial completion date: Nov 2022 --> May 2023 | Trial primary completion date: Nov 2022 --> May 2023
  • ||||||||||  AiRuiKa (camrelizumab) / HLB Bio Group
    Retrospective data, Review, Journal:  Efficacy and safety of camrelizumab combined with TACE for hepatocellular carcinoma: a systematic review and meta-analysis. (Pubmed Central) -  Feb 6, 2024   
    The 5-yr updated analysis further supports Camre + Carbo-Pem as a standard-of-care for previously untreated, advanced non-squamous NSCLC without EGFR/ALK alterations. Combination therapy of TACE plus camrelizumab has shown notable clinical benefits, improved survival, and a manageable safety profile in patients with HCC, but it is essential to monitor and manage the specific toxicities, especially for the camrelizumab-related AEs.
  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
    Trial completion:  CARES-310: A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC (clinicaltrials.gov) -  Feb 6, 2024   
    P3,  N=543, Completed, 
    Combination therapy of TACE plus camrelizumab has shown notable clinical benefits, improved survival, and a manageable safety profile in patients with HCC, but it is essential to monitor and manage the specific toxicities, especially for the camrelizumab-related AEs. Active, not recruiting --> Completed
  • ||||||||||  AiRuiKa (camrelizumab) / HLB Bio Group, Tecentriq (atezolizumab) / Roche
    Journal, Combination therapy, PD(L)-1 Biomarker, IO biomarker:  Immunotherapy in Combination with Chemotherapy for Triple-Negative Breast Cancer. (Pubmed Central) -  Jan 30, 2024   
    In many clinical trials, the overall response rate and survival were better in patients treated with these drug combinations than those treated with chemotherapy alone. Although definitive treatments are not within reach, efforts to gain a deeper understanding of combination immunotherapy have the potential to overcome the urge for safe and effective treatments.
  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
    Trial completion:  Camrelizumab Combined With Apatinib and Capecitabine in Patients With Advanced Biliary Tract Cancer. (clinicaltrials.gov) -  Jan 30, 2024   
    P2,  N=28, Completed, 
    Although definitive treatments are not within reach, efforts to gain a deeper understanding of combination immunotherapy have the potential to overcome the urge for safe and effective treatments. Not yet recruiting --> Completed
  • ||||||||||  AiRuiKa (camrelizumab) / HLB Bio Group
    New P3 trial:  Total Neoadjuvant Treatment  (clinicaltrials.gov) -  Jan 29, 2024   
    P3,  N=472, Recruiting, 
  • ||||||||||  Review, Journal:  Advances and challenges of first-line immunotherapy for non-small cell lung cancer: A review. (Pubmed Central) -  Jan 23, 2024   
    Results from first-line trials have shown that almost all driver-negative mNSCLC are treated with ICIs and significantly prolong patient survival; however, the low response rate and adverse reactions to immunotherapy remain to be addressed. Here, we summarize the use of ICIs, including monotherapy and combination therapy, in the first-line treatment of mNSCLC in recent years and discuss the low response rate and adverse reactions of ICIs as well as the challenges and expectations for the first-line treatment of mNSCLC in the future.
  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
    P2 data, Journal, PD(L)-1 Biomarker, IO biomarker:  Camrelizumab combined with apatinib and nanoparticle albumin-bound paclitaxel in lung adenocarcinoma (CAPAP-lung): a single-arm phase II study. (Pubmed Central) -  Jan 23, 2024   
    P2
    Heath Research Foundation of Chinese Society of Clinical Oncology, Hunan Provincial Natural Science Foundation of China, Hunan Cancer Hospital Climb Plan, Sister Institution Network Fund of The University of Texas MD Anderson Cancer Center, The Science and Technology Innovation Program of Hunan Province, and Suzhou Sheng Diya Biomedical Co., Ltd, a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Shanghai, China).
  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
    Trial completion date, Trial primary completion date:  Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb HCC (clinicaltrials.gov) -  Jan 23, 2024   
    P2/3,  N=62, Recruiting, 
    In patients with RM-NPC, apatinib plus camrelizumab showed promising antitumor activity and manageable toxicities. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: May 2023 --> Sep 2024
  • ||||||||||  Retrospective data, Journal:  New First-line Immunotherapy-based Therapies for Unresectable Hepatocellular Carcinoma: A Living Network Meta-analysis. (Pubmed Central) -  Jan 22, 2024   
    The combination therapies, apart from atezolizumab plus cabozantinib in OS and durvalumab plus tremelimumab in PFS, had higher P-score than single-agent MTAs or ICIs...This NMA demonstrated that atezolizumab plus bevacizumab remains the stand of care and confers comparable survival benefits to sintilimab plus IBI305 and camrelizumab plus apatinib in first-line therapy for uHCC. The optimal treatment algorithms should consider efficacy, safety, and etiology.
  • ||||||||||  5-fluorouracil / Generic mfg.
    Journal, Combination therapy, Metastases:  Development and validation of a nomogram to predict pathological complete response in patients with locally advanced gastric adenocarcinoma treated with neoadjuvant chemotherapy in combination with PD-1 antibodies. (Pubmed Central) -  Jan 10, 2024   
    Clinical and pathological characteristics of patients with GC who received neoadjuvant chemotherapy combined with PD-1 inhibitor (camrelizumab) therapy and radical gastrectomy between January 2019 and December 2020 at the Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital were retrospectively analyzed...The neoadjuvant regimen consisted of a combination of PD-1 inhibitor and fluorouracil analogues plus oxaliplatin, comprising two drugs...Neoadjuvant chemotherapy combined with PD-1 antibodies may be the preferred option for patients with advanced gastric adenocarcinoma who have a small tumor diameter, no or few lymph node metastases, and high CPS. The presented nomogram model exhibits the potential to predict pCR in advanced gastric adenocarcinoma patients, showcasing satisfactory predictive performance and potentially facilitating the implementation of personalized treatment strategies.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, AiRuiKa (camrelizumab) / HLB Bio Group
    Journal, Checkpoint inhibition:  Variable PD-1 glycosylation modulates the activity of immune checkpoint inhibitors. (Pubmed Central) -  Jan 9, 2024   
    We then provide evidence that the concentration of fucosylated PD-1 in the blood of non-small-cell lung cancer patients varies across different stages of disease. This study illustrates how glycoprofiling of surface receptors and related circulating forms can inform the development of differentiated antibodies that discriminate glycosylation variants and achieve enhanced selectivity, and paves the way toward the implementation of personalized therapeutic approaches.
  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group, Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, AiRuiKa (camrelizumab) / HLB Bio Group
    P2 data, Journal, Metastases:  Neoadjuvant camrelizumab and apatinib combined with chemotherapy versus chemotherapy alone for locally advanced gastric cancer: a multicenter randomized phase 2 trial. (Pubmed Central) -  Jan 8, 2024   
    P2
    In this multicenter, randomized, phase 2 trial (NCT04195828), patients with gastric adenocarcinoma (clinical T2-4N?+?M0) were randomly assigned (1:1) to receive neoadjuvant camrelizumab and apatinib combined with nab-paclitaxel plus S-1 (CA-SAP) or chemotherapy SAP alone (SAP) for 3 cycles...Survival results were not reported due to immature data. Camrelizumab and apatinib combined with chemotherapy as a neoadjuvant regimen was tolerable and associated with favorable responses for LAGC.
  • ||||||||||  Tyvyt (sintilimab) / Innovent Biologics, Eli Lilly, AiRuiKa (camrelizumab) / HLB Bio Group
    Review, Journal, Checkpoint inhibition, PD(L)-1 Biomarker, IO biomarker:  Immune checkpoint inhibitors in gastrointestinal malignancies: an Umbrella review. (Pubmed Central) -  Jan 6, 2024   
    We also assessed the correlation of PD-L1 expression as well as microsatellite status with the extent of the response to ICIs; overall, high expression of PD-L1 in GI cancers is associated with better response to ICIs, however, additional studies are required to precisely elaborate ICI responses with respect to microsatellite status in different GI tumors. Despite encouraging ICI efficacy in some GI cancers, a greater number of serious and fatal adverse events have been observed; further highlighting the fact that ICI therapy in GI cancers is not without cost, and further studies are required to utmost optimization of this approach in GI cancers.
  • ||||||||||  AiRuiKa (camrelizumab) / HLB Bio Group
    Trial completion, Trial completion date, Trial primary completion date:  Microwave Ablation Combined With Camrelizumab in the Treatment of Early Breast Cancer (clinicaltrials.gov) -  Jan 5, 2024   
    P2,  N=60, Completed, 
    Despite encouraging ICI efficacy in some GI cancers, a greater number of serious and fatal adverse events have been observed; further highlighting the fact that ICI therapy in GI cancers is not without cost, and further studies are required to utmost optimization of this approach in GI cancers. Recruiting --> Completed | Trial completion date: Dec 2022 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Apr 2023