AiTan (rivoceranib) / Jiangsu Hengrui Pharma, HLB Bio Group, Bukwang Pharma, Advenchen - LARVOL DELTA

Exploratory phase II trial of camrelizumab (an anti-PD-1 antibody) combined with apatinib (a VEGFR-2 inhibitor) and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and biomarker analysis (SABCS 2025) - P2 | "The treatment regimen consisted of camrelizumab (200 mg intravenously every 2 weeks, 12 cycles), apatinib (250 mg orally daily), and alternating chemotherapy [nab-paclitaxel (d1, 8, 15 every 4 weeks) for 4 cycles and epirubicin plus cyclophosphamide (every 2 weeks) for 4 cycles]. From June 2023 to April 2024, 35 patients were enrolled, of whom 1 patient withdrew due to adverse reaction intolerance. In conclusion, camrelizumab and apatinib combined with chemotherapy have good clinical efficacy and good safety as neoadjuvant treatments for stage II-III TNBC, warranting further investigation and potential clinical application. This innovative dual-score system stratifies pretreatment prognosis (PRPscore) and dynamically evaluates therapeutic efficacy (EAscore), enabling precision neoadjuvant optimization."

Biomarker • Clinical • IO biomarker • P2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • CXCL1 • IL17A • IL18 • MMP7 • PD-L1 • TP53

Iparomlimab and Tuvonralimab in Combination with Nab-Paclitaxel and Apatinib as Second-Line Therapy for Advanced Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma: A Single-Center, Single-Arm IIT Study (ChiCTR) - P2 | N=20 | Not yet recruiting | Sponsor: Shanghai East Hospital; Shanghai East Hospital

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • HER-2 • MSI

Apatinib mesylate in the treatment of advanced triple-negative breast cancer. (PubMed, Oncol Res Treat) - "This review examines the role of apatinib in treating TNBC and explores its potential mechanisms when combined with chemotherapeutic agents and ICIs for advanced TNBC in the era of immunotherapy."

Journal • Review • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

The mechanism of apatinib reprogramming arginine metabolism in cervical cancer to enhance the anti-tumor effect of anti-PD-1 immunotherapy (ESGO 2026) - "Mice receiving apatinib plus anti-PD-1 showed slower growth, higher intratumoral CD8+ infiltration and stronger cytotoxic cytokine release. Targeted metabolomics demonstrated that apatinib lowered intracellular arginine in tumor cells while raising it in CD8+ T cells.Conclusion In patients achieving durable benefit from apatinib plus camrelizumab, serum arginine levels fall and cytotoxic T-cell function is boosted; mechanistically, apatinib halts arginine uptake by cervical-cancer cells and donates the amino acid to CD8+ T cells, thereby markedly amplifying their killing capacity."

IO biomarker • Cervical Cancer • Oncology • Solid Tumor • CD8 • GZMB • IFNG • TNFA

Case report: Immune checkpoint inhibitor-induced fulminant diabetic ketoacidosis: a case-based review and considerations for immunotherapy discontinuation. (PubMed, Front Immunol) - "An elderly male diagnosed with Stage IV LUAD achieved sustained stable disease (SD) and symptomatic improvement through a sequential therapeutic strategy, including platinum-based chemotherapy followed by the PD-1 inhibitor sintilimab combined with anti-angiogenic agents (apatinib or anlotinib). This case demonstrates that while ICIs can provide exceptional long-term benefits in advanced NSCLC, particularly in patients with highly immunogenic mutation profiles, they may also trigger late-onset fatal irAEs. Our findings underscore the imperative for close, long-term metabolic surveillance throughout the course of immunotherapy, regardless of treatment duration or radiological stability."

Checkpoint inhibition • IO biomarker • Journal • Review • Diabetes • Endocrine Cancer • Lung Adenocarcinoma • Lung Cancer • Metabolic Disorders • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • TP53

Multi-Targeted TKIs in Patients with Advanced Ewing Sarcoma: A Systematic Review and Single-Arm Meta-Analysis. (PubMed, Cancers (Basel)) - "The following TKIs were evaluated: cabozantinib, regorafenib, apatinib, anlotinib, sorafenib, lenvatinib, sunitinib, fruquintinib, and imatinib...Efficacy was consistently seen in both clinical trials and real-world studies. Nonetheless, there are important differences in study design and population that may limit our interpretation of efficacy and toxicity findings."

Journal • Retrospective data • Review • Ewing Sarcoma • Oncology • Sarcoma • Solid Tumor

ESIRA, a novel framework integrating efficacy and safety for evaluating first-line treatments in advanced hepatocellular carcinoma. (PubMed, Sci China Life Sci) - "Nivolumab plus ipilimumab ranked highest when the safety weight exceeded 0.7, whereas sintilimab plus bevacizumab and camrelizumab plus apatinib rose sharply in ranking when the efficacy weight exceeded 0.8. In addition, ESIRA rankings were reproduced in two independent validation cohorts, further demonstrating consistency across heterogeneous datasets. By quantitatively integrating multiple clinical outcomes, ESIRA provides a structured approach to treatment selection that may better capture the trade-offs encountered in real-world clinical decision-making for advanced HCC."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer (clinicaltrials.gov) - P2 | N=56 | Not yet recruiting | Sponsor: Eastern Hepatobiliary Surgery Hospital

New P2 trial • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Efficacy and safety of first-line immunotherapy and targeted therapy in advanced HCC: a network meta-analysis with subgroup analysis based on HBV and HCV infection. (PubMed, Front Immunol) - "In the overall population, regimens with significant OS advantage over sorafenib included sintilimab plus bevacizumab biosimilar (HR = 0.57, 95% CrI 0.43-0.75), camrelizumab plus rivoceranib (HR = 0.62, 0.48-0.79), and atezolizumab plus bevacizumab (HR = 0.66, 0.51-0.84). For PFS, top-ranked combinations were camrelizumab plus rivoceranib (HR = 0.52, 0.41-0.66), anlotinib plus penpulimab (HR = 0.53, 0.41-0.68), lenvatinib plus pembrolizumab (HR = 0.55, 0.44-0.68), and sintilimab plus bevacizumab biosimilar (HR = 0.56, 0.45-0.69)...Regarding safety, tislelizumab (RR = 0.42, 0.33-0.52) and nivolumab (RR = 0.45, 0.36-0.56) were associated with the lowest incidence of AEs≥3...In non-viral HCC, the STRIDE regimen (single priming dose tremelimumab plus durvalumab) was the only regimen to significantly improve OS (HR = 0.75, 0.59-0.96)...This etiology-stratified evidence..."

Clinical • Journal • Retrospective data • Review • Hepatitis C • Hepatocellular Cancer • Infectious Disease • Oncology • Solid Tumor

A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=94 | Not yet recruiting | Sponsor: Eastern Hepatobiliary Surgery Hospital

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

A Study of Apatinib + Lenvatinib Conversion Followed by Surgical Resection for Unresectable Advanced HCC: A Prospective, Single-Arm, Historical Control, IIT Study (ChiCTR) - P=N/A | N=73 | Not yet recruiting | Sponsor: Affiliated hangzhou first people's hospital, zhejiang university school of medicine; Affiliated hangzhou first people's hospital, zhejiang university

New trial • Hepatocellular Cancer • Oncology • Solid Tumor

Effect of Huaier Granule on Nephrotoxicity Associated With Targeted Therapy for Advanced Hepatobiliary Malignancies. (clinicaltrials.gov) - P2 | N=76 | Completed | Sponsor: Fudan University | Recruiting ➔ Completed | Phase classification: P4 ➔ P2 | N=53 ➔ 76 | Trial completion date: Apr 2025 ➔ Dec 2025 | Trial primary completion date: Feb 2025 ➔ Sep 2025

Adverse events • Enrollment change • Phase classification • Trial completion • Trial completion date • Trial primary completion date • Biliary Cancer • Oncology

Fuzuloparib with or without apatinib in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations (FABULOUS): interim analysis of a multicentre, three-arm, open-label, randomised, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Fuzuloparib, either as monotherapy or in combination with apatinib, provided statistically significant improvements in progression-free survival compared with chemotherapy in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations, presenting as new treatment options."

Clinical • Journal • P3 data • P3 data: top line • Breast Cancer • Cardiovascular • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hypertension • Oncology • Septic Shock • Solid Tumor • BRCA1 • BRCA2 • HER-2

Perioperative camrelizumab plus rivoceranib in resectable hepatocellular carcinoma (CARES-009): A randomized, multicenter, phase III trial (ESMO 2025) - P2/3 | "Grade ≥3 treatment-related adverse events occurred in 37.6% of patients in the perioperative group. Conclusions Perioperative camrelizumab plus rivoceranib significantly improved EFS and MPR compared with surgery alone in patients with resectable HCC at intermediate or high-risk of recurrence."

Clinical • P3 data • Hepatocellular Cancer • Oncology • Solid Tumor

Camrelizumab Plus Apatinib in Combination With GEMOX (Gemcitabine and Oxaliplatin ) in Patients With Locally Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: First Affiliated Hospital of Zhejiang University | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2025 ➔ Dec 2026

Enrollment closed • Trial completion date • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician's choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01). (ASCO 2025) - P1/2 | "For TPC arm, one of the standard of care (SOC) drugs (apatinib, paclitaxel, docetaxel, irinotecan or nivolumab) was given per physician's decision... This is the first confirmatory RCT of CAR T-therapy in solid tumors. Satri-cel demonstrated significant PFS improvement and an obvious OS benefit with a manageable safety profile. These results support satri-cel as a potential new SOC for advanced G/GEJC."

CAR T-Cell Therapy • Clinical • Metastases • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

Sequential hepatectomy for hepatocellular carcinoma with inadequate future-liver-remnant after portal vein ligation in combination with apatinib plus camrelizumab (PLACES): a single-arm prospective pilot study. (PubMed, Hepatobiliary Surg Nutr) - P=N/A | "Compared with the historical ALPPS group, the PLACES group demonstrated better higher EFS (not reach vs. 10.2 months, P=0.040) and overall survival (not reach vs. 19.5 months, P=0.046). PVL combined with apatinib and camrelizumab emerged as a promising therapy for HCC with inadequate FLR, demonstrating both efficacy and safety (chictr.org number, ChiCTR2000033692)."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Efficacy and safety of camrelizumab-based regimens in advanced squamous cell carcinoma patients: a prospective multicenter study (Front Pharmacol) - "Objective response rate and disease control rate were 18.8% and 84.4%, respectively. Camrelizumab-based regimens achieved the median [95% confidence interval (CI)] progression-free survival (PFS) and overall survival (OS) of 6.8 (5.4-8.2) and 17.4 (12.8-21.9) months, respectively. Compared to patients receiving camrelizumab monotherapy, PFS was prolonged in patients receiving camrelizumab combination therapy (P=0.007), especially in patients receiving camrelizumab plus chemotherapy (P=0.017), camrelizumab plus apatinib (P=0.041), and camrelizumab plus chemotherapy and apatinib (P=0.014)."

Clinical data • Esophageal Cancer

Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial. (PubMed, Lancet) - P1/2 | "This is the first randomised controlled trial of CAR T-cell therapy in solid tumours globally. Satri-cel treatment resulted in a significant improvement in progression-free survival, with a manageable safety profile. These results support satri-cel as a new third-line treatment for advanced gastric or gastro-oesophageal junction cancer patients."

Journal • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

HLB advances China review of Rivoceranib combo as US resubmission proceeds (Chosun Biz) - "HLB said on the 2nd that its Chinese partner Jiangsu Hengrui Pharmaceuticals recently received a notice from China's National Medical Products Administration (NMPA) that it has begun the substantive review of the combination therapy of 'Rivoceranib, Camrelizumab, and transarterial chemoembolization (TACE)' for patients with unresectable hepatocellular carcinoma. The application is based on the results of a phase 3 clinical trial conducted with 423 patients at 34 medical institutions in China."

China filing • Hepatocellular Cancer

Camrelizumab plus apatinib in patients with advanced or refractory chordoma: A single-arm, open-label, phase 2 trial. (ASCO 2025) - P2 | "The combination of camrelizumab and apatinib demonstrated promising efficacy and manageable toxicity in chordoma treatment. Furthermore, CDKN2A alterations (CND or HD) were associated with poorer outcomes, providing a potential biomarker for therapeutic stratification."

Clinical • IO biomarker • Metastases • P2 data • Chordoma • CDKN2A

MA-GC-II-019: Camrelizumab Combined With or Without Apatinib and SOX of Neoadjuvant Treatment for Gastric Cancer (clinicaltrials.gov) - P2 | N=80 | Active, not recruiting | Sponsor: Ruijin Hospital | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Neoadjuvant camrelizumab plus apatinib and temozolomide for resectable stage II/III acral melanoma: The CAP 03-NEO trial. (ASCO 2025) - P2 | "Stage 1 results of CAP 03-NEO demonstrated the potential of neoadjuvant camrelizumab, apatinib and temozolomide in pts with resectable stage II/III AM. The pNR result support advancing to stage 2 to further assess the efficacy and safety of this regimen in pts with stage III disease."

Clinical • Constipation • Gastroenterology • Gastrointestinal Disorder • Melanoma • Oncology • Solid Tumor

An Exploratory Clinical Study of Adebrelimab Combined with Apatinib and Chemotherapy as Neoadjuvant Therapy for Initially Unresectable Stage III Non-Small Cell Lung Cancer (ChiCTR) - P=N/A | N=52 | Not yet recruiting | Sponsor: Harbin Medical University Cancer Hospital; Harbin Medical University Cancer Hospital

New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Elevar Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for Rivoceranib in Combination with Camrelizumab as a First-line Systemic Treatment for Unresectable Hepatocellular Carcinoma (GlobeNewswire) - "The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 23, 2026....Elevar on Jan. 23, 2026, submitted the NDA for rivoceranib, while Hengrui Pharma submitted a biologics license application (BLA) for camrelizumab....In Elevar’s global Phase 3 CARES-310 study, the camrelizumab plus rivoceranib combination therapy achieved a median overall survival of 23.8 months in patients with uHCC, representing the longest overall survival reported to date among first-line treatments for uHCC."

FDA filing • PDUFA • Hepatocellular Cancer