7 recruiting, 2 active not recruiting, 1 terminated. 7 Phase 2, 3 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Recruiting 4, Active not recruiting 2, Terminated 1 |
| Phase 3 | 3 | Recruiting 3 |
| Phase 1 | 1 | Active not recruiting 1 |
Follow Cadonilimab (AK104): new trials by email Literature Review of Cadonilimab (AK104) trials Research Report on Cadonilimab (AK104)
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02) Second-Line Chemotherapy, Radiation Therapy, Cadonilimab (AK104) - Colon Rectal Cancer Adenocarcinoma, Peritoneal (Metastatic) Cancer | Phase 3 | Recruiting | Fudan University | 198 | 2026-10-01 | 2026-10-13 |
| Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer Cadonilimab (AK104), Oxaliplatin, Capecitabine - Resectable Colon Cancer, MSI-H/dMMR Colorectal Cancer | Phase 3 | Recruiting | Akeso | 386 | 2026-04-15 | 2026-04-22 |
| Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC) Cadonilimab (AK104), Cisplatin, Paclitaxel - Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma | Phase 2 | Recruiting | Akeso | 90 | 2025-12-19 | 2025-12-31 |
| Intrathecal Combination of Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis Cadonilimab (AK104), Pemetrexed (Alimta) - Leptomeningeal Metastasis | Phase 1 / Phase 2 | Active not recruiting | Guangzhou Medical University | 39 | 2025-03-07 | 2026-10-13 |
| A Prospective Study of Cadonilimab in Hepatocellular Carcinoma After Radical Surgery With High Risk of Recurrence Cadonilimab (AK104) - Hepatocellular Carcinoma (HCC) | Phase 2 | Terminated | Guangxi Medical University | 45 | 2025-02-16 | 2026-02-18 |
| SBRT, Chemotherapy, and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC) Cadonilimab (AK104) - Breast Cancer | Phase 2 | Recruiting | Hubei Cancer Hospital | 51 | 2024-11-28 | 2024-12-02 |
| A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC Cadonilimab (AK104), Sugemalimab - NSCLC (Non-small Cell Lung Cancer) | Phase 3 | Recruiting | Akeso | 560 | 2024-11-12 | 2025-03-12 |
| Cadonilimab(AK104) Plus Concurrent Chemoradiotherapy in Patients With Locally Advanced, Unresectable, Stage III NSCLC Cadonilimab (AK104) - NSCLC, Locally Advanced Lung Carcinoma | Phase 2 | Active not recruiting | Fudan University | 41 | 2024-07-01 | 2025-09-24 |
| A Prospective, Open-label, Single-center, Single-arm Phase II Clinical Study of Cadonilimab (AK104) Combined With Monotherapy Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer With Negative Driver Genes and Failed Immunotherapy Cadonilimab (AK104) - Non-small Cell Lung Cancer | Phase 2 | Recruiting | Xin-Hua Xu | 48 | 2024-03-01 | 2024-06-21 |
| Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer mFOLFOXIRI + Cadonilimab, mFOLFOX6, mFOLFOXIRI - Colorectal Cancer | Phase 2 | Recruiting | Sun Yat-sen University | 143 | 2023-07-10 | 2025-07-23 |
Carcinoma, Non-Small-Cell Lung (2) · Breast Neoplasms (1) · Carcinoma, Hepatocellular (1) · Colorectal Neoplasms (1) · Meningeal Carcinomatosis (1) · Neoplasm Metastasis (1) · Neoplasms (1)
Akeso (3) · Fudan University (2) · Guangxi Medical University (1) · Guangzhou Medical University (1) · Hubei Cancer Hospital (1) · Sun Yat-sen University (1) · Xin-Hua Xu (1)
China (10)
Jinming Yu, MD (1) · Ruihua Xu, PhD (1) · Xiaolong Yan (1) · Yanhong Deng, Ph.D (1) · Zhenyu Pan, PhD, MD (1)