36 recruiting, 24 not yet recruiting, 13 unknown, 8 active not recruiting. 67 Phase 2, 9 Phase 1, 9 Phase 3, 4 Not applicable, 1 Phase 4.
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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 |
|---|---|---|---|---|---|---|
| Chemotherapy Combined With or Without Short-Course Radiotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for High-Risk Locally Advanced Colon Cancer With pMMR/MSS short-course radiotherapy, Serplulimab, CapOx(Capecitabine+ Oxaliplatin) - Locally Advanced Colon Cancer, pMMR | Phase 3 | Not yet recruiting | Fudan University | 480 | 2026-10-15 | 2026-10-16 |
| A Prospective, Single-center, Phase II Study of Neoadjuvant Serplulimab Plus XELOX and Bevacizumab in Locally Advanced Rectal Cancer Serplulimab, Bevacizumab, Oxaliplatin - Locally Advanced Rectal Cancer | Not applicable | Not yet recruiting | Tang-Du Hospital | 48 | 2026-10-15 | 2026-10-13 |
| Efficacy and Safety of Intraoperative Radiotherapy Combined With Serplulimab Plus Chemotherapy Versus Serplulimab Plus Chemotherapy as Neoadjuvant Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma Serplulimab, Intraoperative exploration plus intraoperative radiotherapy, Intraoperative exploration without intraoperative radiotherapy - Gastric or Gastroesophageal Junction Adenocarcinoma | Phase 2 | Not yet recruiting | The First Affiliated Hospital with Nanjing Medical University | 68 | 2026-10-15 | 2026-10-13 |
| JDB153 Combined With Serplulimab for Pancreatic Cancer After Standard Treatment Failure JDB153, Serplulimab - Refractory Pancreatic Ductal Adenocarcinoma, Refractory Pancreatic Adenocarcinoma | Phase 1 / Phase 2 | Not yet recruiting | West China Hospital | 10 | 2026-09-01 | 2026-08-19 |
| Serplulimab Combined With CAPOX and Bevacizumab as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer Serplulimab, CAPOX, Bevacizumab - Locally Advanced Colorectal Cancer | Phase 2 | Not yet recruiting | Xijing Hospital | 85 | 2026-09-01 | 2026-09-15 |
| Exploring the Efficacy of Ferrous Sulfate/Ferrous Succinate Combined With Serplulimab and SOX Regimen in Neoadjuvant Therapy for Gastric Cancer: A Prospective Cohort Study Ferrous succinate, Ferrous Sulfate, Serplulimab - Gastric Neoplasms | Phase 2 | Not yet recruiting | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | 54 | 2026-09-01 | 2026-10-14 |
| A Study of YL201 in Combination With Serplulimab in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer YL201, Serplulimab, Carboplatin - SCLC, Extensive Stage | Phase 3 | Recruiting | MediLink Therapeutics (Suzhou) Co., Ltd. | 442 | 2026-08-18 | 2026-08-24 |
| Luvometinib in Combination With Serplulimab for NF2-Related Tumors Luvometinib, Serplulimab - NF2-related Schwannomatosis, NF2 | Phase 1 / Phase 2 | Not yet recruiting | Beijing Tiantan Hospital | 30 | 2026-07-31 | 2026-07-16 |
| Platform Research for Innovative Medicines in NF2-SWN (PRIME-NF2) Selumetinib 25mg/m2, Luvometinib, Serplulimab - Neurofibromatosis Type 2, Vestibular Schwannoma | Phase 2 | Not yet recruiting | Beijing Tiantan Hospital | 200 | 2026-07-18 | 2026-07-20 |
| Perioperative HLX10 (Serplulimab) With S-1+Oxaliplatin (SOX) in Locally Advanced and PD-L1-Positive Gastric or Esophagogastric Junction Adenocarcinoma serplulimab, Placebo - Gastric Adenocarcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma | Phase 2 | Recruiting | National Cancer Center, Japan | 136 | 2026-07-15 | 2026-08-05 |
| HIPEC Priming Followed by Serplulimab Plus SOX/XELOX in Locally Advanced Gastric Cancer Hyperthermic Intraperitoneal Chemotherapy, Serplulimab, S-1 - Locally Advanced Gastric Cancer, Gastric Adenocarcinoma | Phase 2 | Recruiting | Shanghai Changzheng Hospital | 48 | 2026-07-13 | 2026-10-22 |
| Neoadjuvant Moderately Hypofractionated Radiotherapy Combined With Chemotherapy and Immunotherapy for High-risk pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Multi-center Randomized Control Phase II Trial Moderately Hypofractionated Radiotherapy, Serplulimab, CapOx+Long-course radiotherapy - Rectal Cancer, Moderately Hypofractionated Radiotherapy | Phase 2 | Not yet recruiting | Fudan University | 165 | 2026-06-01 | 2026-04-14 |
| Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50% Serplulimab - NSCLC (Non-small Cell Lung Cancer) | Phase 2 | Recruiting | Tang-Du Hospital | 60 | 2026-05-13 | 2026-05-19 |
| A Phase II Randomized Trial of Serplulimab With Second-Line Chemo/Targeted Therapy for Early Relapse Colorectal Cancer After Adjuvant Chemotherapy Serplulimab, Second-Line Chemo/Targeted Therapy - Colorectal Cancer, Relapse | Phase 2 | Recruiting | Fudan University | 40 | 2026-05-10 | 2026-05-22 |
| A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal Cancer Serplulimab, Oncolytic Virus H101, XELOX Chemotherapy - Rectal Neoplasms, Rectal Adenocarcinoma | Phase 2 | Not yet recruiting | Chongqing University Cancer Hospital | 20 | 2026-05-01 | 2026-04-22 |
| Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer ZG006, Serplulimab - Small Cell Lung Cancer | Phase 1 | Recruiting | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | 100 | 2026-04-21 | 2026-04-28 |
| Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer Serplulimab, SHR-A1811 - Breast Cancer, Serplulimab Combined With SHR-A1811 as Neoadjuvant Therapy for Triple-Negative Breast Cancer | Phase 2 | Not yet recruiting | Xijing Hospital | 84 | 2026-03-25 | 2026-03-12 |
| Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC HLX10, Chemotherapy, Nimotuzumab - Resectable Esophageal Squamous Cell Carcinoma | Phase 2 | Recruiting | Tianjin Medical University Cancer Institute and Hospital | 46 | 2026-03-12 | 2026-03-11 |
| A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer HLX07, HLX07 placebo, Serplulimab - Squamous NSCLC | Phase 2 / Phase 3 | Not yet recruiting | Shanghai Henlius Biotech | 720 | 2026-03-01 | 2026-01-06 |
| FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer Serplulimab, Fruquintinib, mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU) - Colorectal Cancer (Locally Advanced or Metastatic), Colorectal Cancer Microsatellite Stable (MSS) | Phase 4 | Not yet recruiting | Ye Xu | 42 | 2026-03-01 | 2026-03-03 |
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Carcinoma, Non-Small-Cell Lung (9) · Small Cell Lung Carcinoma (9) · Colorectal Neoplasms (7) · Stomach Neoplasms (6) · Uterine Cervical Neoplasms (6) · Rectal Neoplasms (4) · Esophageal Squamous Cell Carcinoma (3) · Breast Neoplasms (2) · Colonic Neoplasms (2) · Esophageal Neoplasms (2) · Meningioma (2) · Neurofibromatosis 2 (2) · Neuroma, Acoustic (2) · Pancreatic Neoplasms (2) · Triple Negative Breast Neoplasms (2)
Shanghai Henlius Biotech (11) · Fudan University (8) · Sun Yat-sen University (4) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (3) · Henan Cancer Hospital (3) · RenJi Hospital (3) · Tang-Du Hospital (3) · The First Affiliated Hospital with Nanjing Medical University (3) · Tianjin Medical University Cancer Institute and Hospital (3) · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (3) · Zhejiang Cancer Hospital (3) · Beijing Tiantan Hospital (2) · MediLink Therapeutics (Suzhou) Co., Ltd. (2) · Peking Union Medical College Hospital (2) · West China Hospital (2)
China (72) · Japan (3) · United States (2) · Austria (1) · Czechia (1) · Germany (1) · Greece (1) · Hungary (1) · Latvia (1) · Netherlands (1) · Poland (1) · South Korea (1) · Spain (1)
Beihua Kong, MD.PhD. (1) · Chang Chen, Dr (1) · Dan Cao, MD (1) · Feng Wang (1) · Guonan Zhang (1) · Huichuan Sun, Dr (1) · Jason Wu (1) · Jia Fan (1) · Jie Wang, Dr. (1) · Jin-Ji Yang, PhD (1) · Jinming Yu, MD (1) · Ken Kato, M.D., Ph.D. (1) · Lian Liu (1) · Linqiang Lai, MD. (1)
PMID 37977903, PMID 38309748, PMID 38870931, PMID 40398957, PMID 41538111, PMID 41749205, PMID 42682706