Endostar (recombinant human endostatin) / Simcere - LARVOL DELTA

Endouble 2: SRT Combined With Envafolimab and Endostar in the First-line Treatment of Advanced NSCLC (clinicaltrials.gov) - P2 | N=61 | Not yet recruiting | Sponsor: The First People's Hospital of Lianyungang

IO biomarker • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • ROS1

Triplet Therapy Improves Outcomes in SMARCA4-Mutant Lung Cancer: Integrated Clinical Evidence and Spatial Transcriptomic Insights (IASLC-WCLC 2026) - "This benefit may arise from targeting aberrant angiogenesis and reshaping the tumor immune microenvironment. These findings support triplet therapy as a promising therapeutic strategy and provide a biologically grounded rationale for its use in this high-risk population."

Clinical • IO biomarker • Lung Cancer • Oncology • Solid Tumor • CD8 • SMARCA4

Rh-Endostatin + Sintilimab as First-Line Therapy for EGFR/ALK-Negative Squamous NSCLC: A Single-Arm, Multicenter Phase II Clinical Study (IASLC-WCLC 2026) - "During the induction phase, patients received rh-endostatin (210 mg continuous intravenous infusion, days 1-3), sintilimab (200 mg), and chemotherapy (nab-paclitaxel + carboplatin/cisplatin) every 3 weeks for 4-6 cycles. Secondary endpoints included overall survival (OS), duration of response (DoR), disease control rate (DCR), and safety profile. Exploratory analyses evaluated potential biomarkers and patient-reported quality of life."

Clinical • IO biomarker • P2 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR

Platinum-Free Regimen in Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=145 | Not yet recruiting | Sponsor: Zhejiang Cancer Hospital

New P2 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Mechanical and Metallurgical Evaluation of Four Rotary Nickel-Titanium File Systems: A Multimethod Study. (PubMed, Int Endod J) - "Thermomechanically processed systems exhibited greater flexibility and longer fatigue life, whereas conventional NiTi instruments demonstrated higher rigidity and torque capacity. DSC-based phase characterisation was consistent with the divergent mechanical outcomes observed among groups and offered a plausible metallurgical explanation, although the contributions of alloy processing and instrument design could not be separated within the present study design."

Journal • Fatigue • Musculoskeletal Diseases • Orthopedics

Mechanical and elemental comparison of EndoStar and One Curve nickel-titanium endodontic files: An in vitro study. (PubMed, J Conserv Dent Endod) - "Endostar E3 Azure demonstrated superior cyclic fatigue resistance, higher bending stiffness, and distinct surface chemistry compared with One Curve. Surface elemental variations and heat-treated differences may be associated with the observed mechanical variations; however, mechanistic interpretation requires further phase-transformation analysis."

Journal • Preclinical • Fatigue • Musculoskeletal Diseases • Orthopedics

Endostar combined with PD-1 blockade, radiotherapy, GM-CSF, and IL-2 (PRaG 2.0E) for refractory non-small cell lung cancer: a single-arm, phase II clinical trial (PRaG2.0E Study Protocol). (PubMed, Transl Lung Cancer Res) - P2 | "Concurrently, recombinant human endostatin (Endostar) induces tumor vascular normalization and alleviates immunosuppression by inhibiting regulatory T cells (Tregs)...The study is registered in ClinicalTrials. gov (NCT06047860)."

Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CSF2 • IL2

Efficacy and safety of continuous intra-arterial cisplatin and recombinant human endostatin combined with systemic chemotherapy in osteosarcoma: A phase II study. (ASCO 2026) - P1/2 | "Intra-arterial administration of high-dose rh-endostatin and cisplatin combined with systemic chemotherapy in osteosarcoma appears safe and achieves a good histologic response rate of 50%, compared with a historical rate of 30% with intravenous chemotherapy alone."

Clinical • P2 data • Osteosarcoma • Renal Disease • Sarcoma • Solid Tumor

First-line envafolimab plus recombinant human-endostatin in advanced non-small cell lung cancer with PD-L1 tumor proportion score ≥1% (Endouble): A multicenter, prospective, single-arm, phase 2 trial. (PubMed, Cancer) - "Envafolimab combined with Rh-endostatin demonstrated favorable efficacy and tolerable toxicity in patients with PD-L1-positive, advanced driver-gene negative NSCLC."

IO biomarker • Journal • P2 data • Tumor proportion score • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MMP1 • PD-L1 • TNFRSF6B

Crizotinib or vebreltinib response and resistance in advanced non-small cell lung cancer with MET exon 14 skipping. (PubMed, Discov Oncol) - "While vebreltinib appears clinically advantageous over crizotinib for METex14-mutated NSCLC, the therapeutic benefits did not reach statistical significance in this study. The observed differential response patterns and resistance mechanisms suggest distinct biological behaviors to type Ia and Ib MET TKIs that warrant further investigation. These findings underscore the need for larger prospective studies to validate the potential superiority of vebreltinib and to better characterize the molecular determinants in NSCLC."

IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • EGFR • MET

Phase II study of envafolimab combined with endostar and concurrent chemoradiotherapy in treatment of unresectable locally advanced ESCC (ESTRO 2026) - "Treatment involved involved-field radiotherapy at a dose of 50.4 Gy (1.8 Gy per fraction, once daily), two cycles of paclitaxel liposome (150 mg/m²) and carboplatin (AUC = 5) administered every 4 weeks, and five cycles of endostar (75 mg via 48-hour infusion, once weekly)... The combination of envafolimab, endostar, and concurrent chemoradiotherapy was well-tolerated and demonstrated promising efficacy in patients with LAESCC. The risk of esophageal fistula and bleeding should be fully assessed before treatment."

Metastases • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Disorder • Hematological Disorders • Leukopenia • Neutropenia • Pneumonia • Squamous Cell Carcinoma • Thrombocytopenia

A retrospective, real-world clinical study of the Pacific regimen with or without Endostar in the treatment of stage III unresectable non-small cell lung cancer. (ChiCTR) - P=N/A | N=150 | Sponsor: Henan Cancer Hospital; Henan Cancer Hospital

New trial • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

The Promise of Chemotherapy-Free Strategies in Advanced Driver-Negative NSCLC: A Systematic Review and Network Meta-Analysis of Antiangiogenic Combination Therapies. (PubMed, Cancer Med) - "This network meta-analysis demonstrates that antiangiogenic combinations improve outcomes in driver-negative advanced NSCLC. Endostar + chemotherapy offers the greatest OS benefit, atezolizumab-bevacizumab-chemotherapy improves ORR, and sintilimab-anlotinib provides superior PFS with lower toxicity. Treatment should be tailored based on clinical factors, with further validation in multiethnic trials."

Clinical • Journal • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Long-term survival in a patient with non-small cell lung cancer harboring KRAS G13C and TP53 co-mutations: case report and literature review. (PubMed, Front Med (Lausanne)) - "The patient received first-line and maintenance therapy comprising carboplatin/pemetrexed, camrelizumab, and Endostar/bevacizumab...Our findings suggest that the combination of chemotherapy, immunotherapy, and anti-angiogenic agents may represent a viable therapeutic strategy for patients with KRAS G13C/TP53 co-mutated NSCLC. This case report suggests a potentially promising therapeutic strategy to improve long-term survival in this difficult-to-treat patient population."

IO biomarker • Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • TP53

Anti-Angiogenic Features of Endostatin in Obesity, Liver Fibrosis, and Hepatocellular Carcinoma. (PubMed, Biomedicines) - " Endostar is a promising treatment for HCC and may also become an attractive drug for liver fibrosis. Hence, angiostatic therapy is not without risks and may only be suitable for selected patients."

Journal • Review • Fibrosis • Genetic Disorders • Hepatocellular Cancer • Hepatology • Immunology • Liver Cirrhosis • Liver Failure • Lung Cancer • Obesity • Oncology • Solid Tumor

Molecular Targets of Cervical Cancer and Its Microenvironment: Advances in Treatment. (PubMed, Cancers (Basel)) - "For instance, Bevacizumab, a monoclonal antibody targeting angiogenesis factors, as well as Endostar, a recombinant human endostatin, have been studied and shown to improve survival in advanced disease...Furthermore, antibody-drug conjugates such as Tisotumab Vedotin allow to deliver a highly toxic payload directly to the tumor site by binding to tissue factor, which is highly expressed in cervical tumor cells...However, more robust clinical trials are needed before these vaccines can be effectively and safely used clinically. Finally, several ongoing trials are currently evaluating new therapeutic modalities and combinations of the currently available tools in the cervical cancer treatment armamentarium."

Journal • Review • Cervical Cancer • Oncology • Solid Tumor

Safety,efficacy and mechanisms of envolimab and S-1 systemic therapy combined with intraperitoneal endostar in the treatment of gastric/gastric-oesophageal junction adenocarcinoma with malignant ascites in elderly patients over 70 years. (ChiCTR) - P=N/A | N=30 | Recruiting | Sponsor: Beijing Hospital; Beijing Hospital

New trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology

Endostar combined with docetaxel or cisplatin in the management of malignant ascites through hyperthermic intraperitoneal chemotherapy: A retrospective cohort study. (PubMed, Oncol Lett) - "However, it is worth noting that the incidence of nephrotoxicity was higher in the cisplatin treatment group compared with that in the docetaxel treatment group. Therefore, clinicians should be cautious about nephrotoxicity when administering cisplatin in high-risk patients with PM."

Journal • Retrospective data • Oncology • Renal Disease

Endostar overcomes Osimertinib-resistance mediated EGFR-activation mutation, T790M and cis-C797S triple mutations via enhancing the binding of Osimertinib to EGFR protein. (PubMed, Life Sci) - "This work demonstrated for the first time that Endostar enhanced the antitumor efficacy of Osimertinib, offering a potential therapeutic approach for patients harboring triple mutations."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Successful treatment of lung squamous cell carcinoma with envafolimab, a PD-L1 inhibitor combined with chemotherapy: a case report. (PubMed, Transl Cancer Res) - "Initial immunohistochemistry revealed a tumor proportion score for PD-L1 ≥1%, prompting the following standard first-line therapy as per the guidelines: three cycles of albumin-bound paclitaxel [470 mg, day (d)1], carboplatin (568 mg, d1), and pembrolizumab (200 mg, d1)...Subsequently, second-line therapy comprising two cycles of gemcitabine (1.6 g, d1; 1.4 g, d8), cisplatin (40 mg, d1-3), endostar (30 mg, d1-4), and subcutaneous envafolimab (200 mg, d1) was initiated...It suggests that envafolimab warrants consideration as a viable treatment option in this setting, particularly following the failure of PD-1 inhibitors. Further larger clinical trials need to be conducted to confirm these findings and define its optimal role in the NSCLC treatment sequence."

Journal • Hepatocellular Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions (clinicaltrials.gov) - P3 | N=290 | Active, not recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Oct 2023 ➔ Jun 2026 | Trial primary completion date: Jun 2022 ➔ Feb 2025

Enrollment closed • Trial completion date • Trial primary completion date • Respiratory Diseases

IACE-OS: Intra-arterial Cisplatin Plus Rh-endostatin Combined With Systematic Chemotherapy in Osteosarcoma (clinicaltrials.gov) - P1/2 | N=10 | Completed | Sponsor: Shanghai 6th People's Hospital | Recruiting ➔ Completed | Trial completion date: Oct 2025 ➔ Jul 2025 | Trial primary completion date: Sep 2025 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Case Report: Tail-of-the-curve advantage from immune checkpoint inhibitor-anti-VEGF combination therapy: extended survival in a patient with metastatic lung adenocarcinoma. (PubMed, Front Med (Lausanne)) - "Against this backdrop, we describe the clinical course of a patient with invasive adenocarcinoma of the left upper lobe who underwent surgical resection followed by adjuvant pemetrexed-cisplatin chemotherapy. Two years later, an isolated perihilar recurrence was treated with radical radiotherapy in combination with recombinant human endostatin (Endostar) as a radiosensitizer, after which the patient received four further cycles of the original chemotherapy regimen and subsequently transitioned to pemetrexed maintenance. Thirteen months into maintenance therapy, brain metastases were detected; at this juncture, the patient received whole-brain radiotherapy together with combined sintilimab and Endostar therapy. Although systemic treatment was discontinued after 18 months, the patient maintained disease control for an additional 36 months, consistent with a pronounced tail-of-the-curve effect. This case raises the possibility of integrating ICIs, anti-angiogenic therapy,..."

Checkpoint inhibition • Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efficacy of chemotherapy plus recombinant human endostatin ± immunotherapy in TKI-resistant NSCLC patients (ESMO-IO 2025) - "P-values from Fisher's exact test for categorical variables.Conclusions Adding ICIs to chemotherapy plus Endostar® significantly enhanced rapid and robust disease control in TKI-resistant NSCLC patients, with excellent safety profiles. These findings support the clinical development of this triple combination strategy for TKI-resistant NSCLC."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

SIMCERE PHARMA's ENZESHU and ENDOSTAR Included in China's NRDL (iis.aastocks.com)

Platinum resistant • Reimbursement • Fallopian Tube Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Peritoneal Cancer