- |||||||||| AiTan (rivoceranib) / HLB Bio Group, Keytruda (pembrolizumab) / Merck (MSD), Kaitanni (cadonilimab) / Akesobio
Journal: Successful conversion surgery after comprehensive therapy in a patient with MSI-H but pMMR metastatic gastric mixed adenoneuroendocrine carcinoma: a case report and literature review. (Pubmed Central) - Dec 26, 2024 A 68-year-old male with metastatic gastric MANEC was treated with targeted therapy, immunotherapy, and chemotherapy, including S-1, apatinib, cadonilimab, and paclitaxel...The patient was subsequently treated with a maintenance regimen of S-1 and pembrolizumab...While conversion surgery can be effective in certain contexts, the high likelihood of postoperative recurrence and metastasis, particularly in neuroendocrine components, necessitates cautious consideration. Further research is needed to evaluate the long-term benefits of conversion surgery in metastatic gastric MANEC and to develop tailored therapeutic strategies.
- |||||||||| Review, Journal: Antibodies to watch in 2025. (Pubmed Central) - Dec 23, 2024
The combination of camrelizumab and rivoceranib as a treatment strategy not only improves health outcomes but also represents a cost-effective option across different developmental regions in China. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA
- |||||||||| AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma, Ibrance (palbociclib) / Pfizer, Verzenio (abemaciclib) / Eli Lilly
Enrollment closed, Trial completion date, Real-world evidence: Abemaciclib, Palbociclib or Dalpiciclib Combined with Endocrine Therapy As First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - Dec 20, 2024 P=N/A, N=200, Active, not recruiting, Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Nov 2024 --> Feb 2025
- |||||||||| Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka
Biomarker, Journal, PD(L)-1 Biomarker, IO biomarker: The efficacy of plasma exosomal miRNAs as predictive biomarkers for PD-1 blockade plus chemotherapy in gastric cancer. (Pubmed Central) - Dec 19, 2024 The response of gastric cancer (GC) patients to first-line programmed cell death 1 (PD-1) blockade and S-1 plus oxaliplatin (SOX) chemotherapy varies considerably, and the underlying mechanisms driving this variability remain elusive...Serum exosomes were extracted from 11 GC patients (five in the primary cohort and six in the validation cohort) treated with SOX and camrelizumab (a PD-1 inhibitor)...This study identified specific plasma exosomal miRNAs in GC patients that differ between responders and non-responders to PD-1 monoclonal antibody therapy combined with chemotherapy. These miRNAs could serve as predictive biomarkers, paving the way for precision medicine and personalized therapy in the treatment of GC.
- |||||||||| AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma, Ibrance (palbociclib) / Pfizer, Verzenio (abemaciclib) / Eli Lilly
Clinical, Journal, Real-world evidence, Real-world, Metastases: Real-world comparison of palbociclib, abemaciclib, and dalpiciclib as first-line treatments for Chinese HR+/HER2-metastatic breast cancer patients: a multicenter study (YOUNGBC-28). (Pubmed Central) - Dec 19, 2024 P Palbociclib, abemaciclib, and dalpiciclib demonstrated comparable efficacy in Chinese patients with advanced HR+/HER2- MBC. ClinicalTrials.gov identifier: NCT06344780.
- |||||||||| HRS2398 / Jiangsu Hengrui Pharma
Trial completion, Enrollment change, Trial primary completion date, First-in-human: A First-in-human Study of HRS2398 Tablets in Subjects With Advanced Malignant Tumors (clinicaltrials.gov) - Dec 18, 2024 P1, N=28, Completed, This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP and Eisai Inc. Recruiting --> Completed | N=122 --> 28 | Trial primary completion date: May 2023 --> Feb 2024
- |||||||||| Airui'en (rezvilutamide) / Jiangsu Hengrui Pharma
Clinical, P3 data, Journal, Combination therapy, Patient reported outcomes, Metastases: Patient-reported outcomes of rezvilutamide versus bicalutamide in combination with androgen deprivation therapy in high-volume metastatic hormone-sensitive prostate cancer patients (CHART): a randomized, phase 3 study. (Pubmed Central) - Dec 18, 2024 P3 Additionally, the REZ-ADT group demonstrated a prolonged delay in the deterioration of the total score on the FACT-P questionnaire (25th percentile, 12.8 [95% CI 7.4-20.3] vs. 6.0 months [95% CI 4.6-9.2]; HR 0.66 [95% CI 0.50-0.86]; p?=?0.002), as well as most of the FACT-P subscale scores, in comparison to the BIC-ADT group. In conclusion, REZ-ADT is superior to BIC-ADT regarding the pain alleviation and enhancement of functional scales for high-volume mHSPC.
- |||||||||| NovaTears (perfluorohexyloctane) / Novaliq, Bausch Health, AFT Pharma
Enrollment closed, Trial completion date, Trial primary completion date: A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED) Administering Miebo (clinicaltrials.gov) - Dec 18, 2024 P4, N=216, Active, not recruiting, Current challenges along with the scope of future research directions targeting PD-1/PD-L1 interactions through natural substances are also discussed. Recruiting --> Active, not recruiting | Trial completion date: Feb 2026 --> Nov 2025 | Trial primary completion date: Feb 2026 --> Nov 2025
- |||||||||| AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma, famitinib (SHR 1020) / Jiangsu Hengrui Pharma
Trial completion date, Trial termination: Famitinib Plus SHR6390 and Endocrine Therapy in the Treatment of HR-positive, HER2-negative Advanced Breast Cancer (clinicaltrials.gov) - Dec 17, 2024 P1/2, N=46, Terminated, Recruiting --> Active, not recruiting | Trial completion date: Feb 2026 --> Nov 2025 | Trial primary completion date: Feb 2026 --> Nov 2025 Trial completion date: Jan 2026 --> Jul 2024 | Active, not recruiting --> Terminated; Investigators' decision
- |||||||||| AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
Clinical outcomes of camrelizumab + rivoceranib vs sorafenib (CARES-310) as first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC) of non-viral and viral etiology. (Level 1, West Hall; Poster Bd #: C4) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_536; P3 HCC, hepatocellular carcinoma; mOS, median overall survival; mPFS, median progression-free survival; mo, months; HR, hazard ratio; HCV, hepatitis C virus; HBV, hepatitis B virus, NR, not reached. Results used Cox proportional hazard model.
- |||||||||| retlirafusp alfa (SHR-1701) / Jiangsu Hengrui Pharma
Bifunctional anti-PD-L1/TGF-?RII agent SHR-1701 plus chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): Survival results of a phase II trial. (Level 1, West Hall; Poster Bd #: D26) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_277; P=N/A Eligible pts received SHR-1701 (30mg/kg, iv, d1, q3w) in combination with up to six cycles of albumin-bound paclitaxel (125mg/m2, iv, d1, d8, q3w) and cisplatin (75mg/m2, iv, d1, q3w). The results highlighted that SHR-1701 plus chemotherapy as first-line therapy maintained long-term, durable survival benefit in pts with advanced ESCC.
- |||||||||| Efficacy of PD-1 inhibitor plus chemotherapy versus chemotherapy in advanced esophageal carcinoma: A meta-analysis of phase III clinical trials. (Level 1, West Hall; Poster Bd #: D11) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_263;
PD-1 inhibitors against EC included nivolumab, pembrolizumab, camrelizumab, sintilimab, toripalimab, and serplulimab. PD-1 inhibitor plus chemotherapy as a first-line therapy in advanced EC, mainly in patients with CPS ?10, showed improved antitumor efficacy in terms of superior ORR, OS, and PFS, with a manageable toxicity profile providing a benchmark for future studies.
- |||||||||| AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
Transarterial chemoembolization (TACE) combined with camrelizumab and apatinib versus TACE alone in the treatment of unresectable hepatocellular carcinoma eligible for embolization: A multicenter, open-label, randomized, phase 2 study (CAP-ACE). (Level 2, Ballroom) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_163; P=N/A PD-1 inhibitor plus chemotherapy as a first-line therapy in advanced EC, mainly in patients with CPS ?10, showed improved antitumor efficacy in terms of superior ORR, OS, and PFS, with a manageable toxicity profile providing a benchmark for future studies. The addition of camrelizumab and apatinib to TACE can significantly prolong progression-free survival in patients with unresectable HCC eligible for embolization, with a manageable safety profile.
- |||||||||| Review, Journal: Current Treatment Methods in Hepatocellular Carcinoma. (Pubmed Central) - Dec 17, 2024
Moreover, to maximize outcomes for patients with HCC, the combination of immune checkpoint inhibitors (ICIs) along with targeted therapies or local ablative therapy is being investigated. This review elaborates on the current status of HCC treatment, outlining the most recent clinical study results and novel approaches.
- |||||||||| AiRuiKa (camrelizumab) / HLB Bio Group
Journal, PD(L)-1 Biomarker, IO biomarker: P2RX1-blocked neutrophils induce CD8+ T cell dysfunction and affect the immune escape of gastric cancer cells. (Pubmed Central) - Dec 16, 2024 SHR-1701 combined with XELOX and bevacizumab demonstrated a manageable safety profile and potent antitumor activity in unresectable mCRC. This project validated that the loss of P2RX1 in neutrophils induces CD8+ T cell dysfunction and affects the GC development, indicating that P2RX1 may be an accurate biomarker for predicting ICI response, thus providing a theoretical basis for the clinical application of ICI.
- |||||||||| recaticimab (SHR-1209) / Jiangsu Hengrui Pharma, AiRuiLi (adebrelimab) / Jiangsu Hengrui Pharma
Enrollment open, Trial completion date, Trial primary completion date: Adebrelimab Plus Chemo and Recaticimab in Perioperative Treatment of Resectable NSCLC (clinicaltrials.gov) - Dec 16, 2024 P2, N=35, Recruiting, This project validated that the loss of P2RX1 in neutrophils induces CD8+ T cell dysfunction and affects the GC development, indicating that P2RX1 may be an accurate biomarker for predicting ICI response, thus providing a theoretical basis for the clinical application of ICI. Not yet recruiting --> Recruiting | Trial completion date: Dec 2026 --> Mar 2027 | Trial primary completion date: Dec 2025 --> Aug 2026
- |||||||||| AiTan (rivoceranib) / HLB Bio Group
Trial completion, Trial completion date, IO biomarker: Neoadjuvant Immunotherapy for Resectable Gastric Cancer (clinicaltrials.gov) - Dec 16, 2024 P2, N=25, Completed, Not yet recruiting --> Recruiting | Trial completion date: Dec 2026 --> Mar 2027 | Trial primary completion date: Dec 2025 --> Aug 2026 Recruiting --> Completed | Trial completion date: Dec 2024 --> May 2024
|