AiRuiKa (camrelizumab) / CG Invites, Jiangsu Hengrui Pharma, HLB Bio Group, NPO Petrovax - LARVOL DELTA

Long-term neoadjuvant chemoradiotherapy (nCRT) combined with camrelizumab for locally advanced rectal cancer: a single-arm, prospective, phase II clinical study (ESMO 2025) - No abstract available

Clinical • Metastases • P2 data • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Safety and Efficacy of camrelizumab Based Regimens in Triple Negative Breast Cancer : A Systematic Review and Meta Analysis (ESMO 2025) - No abstract available

Retrospective data • Review • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Neoadjuvant camrelizumab plus chemotherapy versus chemotherapy alone for resectable esophageal squamous cell carcinoma: Primary efficacy/safety results and exploratory single-cell RNA sequencing correlates from a multicenter, prospective, randomized controlled study. (ESMO 2025) - No abstract available

Clinical • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

First-line camrelizumab plus chemotherapy in patients with advanced non-squamous NSCLC and brain metastases: Effectiveness results from a nationwide retrospective study (ESMO 2025) - No abstract available

Metastases • Retrospective data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First-line camrelizumab plus chemotherapy in 3187 patients with advanced non-squamous NSCLC: a nationwide retrospective study (ESMO 2025) - No abstract available

Metastases • Retrospective data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase 2 CAPSTONE trial of first-line camrelizumab plus famitinib for locally advanced or metastatic pulmonary sarcomatoid carcinomas (ESMO 2025) - No abstract available

Clinical • Metastases • P2 data • Oncology • Sarcoma • Solid Tumor

Clinical benefit of camrelizumab (cam) + rivoceranib (rivo) in unresectable hepatocellular carcinoma (uHCC) patients with macrovascular invasion (MVI) and extrahepatic spread (EHS), CARES-310 (ESMO 2025) - No abstract available

Clinical • Hepatocellular Cancer • Oncology • Solid Tumor

Effectiveness and Safety of Camrelizumab Plus Rivoceranib Combined With TACE With or Without HAIC in First-Line Treatment of Unresectable Hepatocellular Carcinoma (ESMO 2025) - No abstract available

Clinical • Hepatocellular Cancer • Oncology • Solid Tumor

Neoadjuvant therapy of sequential transcatheter arterial chemoembolization, camrelizumab and apatinib for single large hepatocellular carcinoma (NEO-START): A randomized controlled trial (ESMO 2025) - No abstract available

Clinical • Hepatocellular Cancer • Oncology • Solid Tumor

Neoadjuvant TACE plus lenvatinib and camrelizumab for borderline resectable hepatocellular carcinoma: Updated results of the BRHCC-I phase Ib/II trial (ESMO 2025) - No abstract available

Clinical • P1/2 data • Hepatocellular Cancer • Oncology • Solid Tumor

Neoadjuvant Camrelizumab with Chemotherapy in PD-L1-Negative Locally Advanced Cervical Cancer: An Open-Label, Multi-Center, Single-Arm, Phase 2 Trial (ESMO 2025) - No abstract available

Clinical • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor

Three-Year Survival Outcomes and Correlative Analyses from the NACI Study: Neoadjuvant Chemotherapy Plus Camrelizumab for Locally Advanced Cervical Cancer (ESMO 2025) - No abstract available

Clinical • Metastases • Cervical Cancer • Oncology • Solid Tumor

Perioperative Camrelizumab plus Rivoceranib in Resectable Hepatocellular Carcinoma (CARES-009): A Randomized, Multicenter, Phase 3 Trial (ESMO 2025) - No abstract available

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

Perioperative camrelizumab plus chemotherapy in locally advanced squamous cell carcinoma of the head and neck (CAMORAL): A multicenter, open-label, randomized, phase II Study (ESMO 2025) - No abstract available

Clinical • Metastases • P2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

The U.S. Food and Drug Administration (FDA) has officially disclosed the reasons for withholding approval of HLB’s liver cancer treatment "Rivoceranib" (Business Korea) - "According to industry sources on Sept. 10, the FDA published a Complete Response Letter (CRL) on its website regarding the combination therapy of Rivoceranib and Chinese Hengrui Pharmaceuticals’ immunotherapy drug 'Camrelizumab'. The FDA stated that approval would only be possible if the two drugs were reviewed together....FDA made it clear that standalone approval for Rivoceranib would not be possible as long as Camrelizumab has not received formal approval in the United States. Furthermore, the FDA cited incomplete bioresearch monitoring (BIMO) inspections at some clinical trial sites....HLB...aiming to reapply within this year."

CRL • Hepatocellular Cancer

DCRT vs. Surgery in Resectable ESCC Patient Achiving cCR/PR After nCI (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Camrelizumab, Pirfenidone, and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer (clinicaltrials.gov) - P1/2 | N=12 | Not yet recruiting | Sponsor: Harbin Medical University

New P1/2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2025 ➔ Sep 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer (clinicaltrials.gov) - P3 | N=443 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Trial completion date: Apr 2025 ➔ May 2027

Trial completion date • Cervical Cancer • Oncology • Solid Tumor

Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2 | N=65 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

New P2 trial • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Camrelizumab-Based Therapy-Induced RCCEP in Advanced NSCLC Patients: A Pooled Analysis of Two Phase III Registration Trials (IASLC-WCLC 2025) - P3 | "The CameL study enrolled patients with stage IIIB-IV non-squamous NSCLC without EGFR or ALK alterations, treated with camrelizumab combined with chemotherapy comprising pemetrexed and carboplatin. The CameL-sq study included patients with stage IIIB-IV squamous NSCLC receiving camrelizumab plus chemotherapy consisting of paclitaxel and carboplatin...Conclusions : This pooled analysis confirmed that RCCEP was relatively prevalent yet predominantly mild in severity among advanced NSCLC patients treated with camrelizumab-based regimens. Notably, the emergence of RCCEP positively correlated with enhanced efficacy, evidenced by improved ORR, prolonged PFS and OS, underscoring RCCEP as a potential predictive biomarker for therapeutic efficacy."

IO biomarker • Metastases • P3 data • Retrospective data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR

Efficacy and safety of camrelizumab plus apatinib for solid tumors: a meta-analysis (Frontiers) - "The Objective Response Rate (ORR) was 40.0%, with a Disease Control Rate (DCR) of 78.0%. Overall Survival (OS) rates at 6, 12, and 24 months were 79.0%, 46.5%, and 16.0%, respectively. Progression-Free Survival (PFS) rates at the same intervals were 48.4%, 19.8%, and 6.7%."

Retrospective data • Oncology • Solid Tumor

A Phase II Trial of Induction Camrelizumab Plus Chemotherapy Followed by Chemoradiotherapy and Consolidation in Limited-Stage SCLC (IASLC-WCLC 2025) - P2 | "Although durvalumab consolidation has enhanced outcomes compared to traditional concurrent chemoradiotherapy (CRT), disease progression remains a formidable challenge...Patients were randomly assigned (1:1) to either an experimental regimen of induction immunotherapy and chemotherapy (two cycles of camrelizumab plus etoposide-platinum [EP] or etoposide-carboplatin [EC]) followed by CRT, prophylactic cranial irradiation (PCI), and up to 12 months of camrelizumab consolidation (camrelizumab group), or a control regimen of induction chemotherapy (EP or EC) followed by CRT and PCI (cCRT group)...Conclusions : These findings suggest that induction camrelizumab plus chemotherapy followed by CRT and camrelizumab consolidation may improve both PFS and OS in LS-SCLC without exacerbating toxicity. Further research to refine treatment sequencing could provide vital improvements in managing this challenging disease."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Pneumonia • Small Cell Lung Cancer • Solid Tumor

A Study of SHR-1802 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P2 | N=25 | Terminated | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | N=124 ➔ 25 | Recruiting ➔ Terminated; Adjustment of R&D strategy

Enrollment change • Trial termination • Solid Tumor

LEAF-02: Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab (clinicaltrials.gov) - P2 | N=141 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor