Clinical trials: Sintilimab
Oral Squamous Cell Carcinoma (OSCC), Head and Neck Squamous Cell Carcinoma
Neoadjuvant Sintilimab Plus Chemotherapy for cT2N0M0 Oral Squamous Cell Carcinoma
This study is a superiority multi-center, open-label, phase III randomized controlled trial. It will further verify the clinical value of xidili single-antibody combined with chemotherapy (albumin paclitaxel and carboplatin) in…
- Conditions
- Oral Squamous Cell Carcinoma (OSCC), Head and Neck Squamous Cell Carcinoma, Early-stage Oral Cancer
- Trial name
- NCT07827872
- Testing
- Sintilimab, Nab-Paclitaxel, Carboplatin
- Where
- China
- Volunteers
- 300 people
- Sponsor
- caohaotian
Nasopharyngeal Carcinoma, Neoplasm Metastasis
Local Ablation Plus Systemic Therapy for Metachronous Liver and/or Lung Oligometastases From Nasopharyngeal Carcinoma
This single-center, open-label, randomized phase II trial evaluates whether CT-guided local ablation of liver and/or lung oligometastases, added to systemic therapy, improves the objective response rate compared with systemic…
- Conditions
- Nasopharyngeal Carcinoma, Neoplasm Metastasis, Lung Metastases, Liver Metastases
- Trial name
- NCT07824856
- Testing
- CT-guided percutaneous local ablation, Gemcitabine, Cisplatin
- Where
- China
- Volunteers
- 138 people
- Sponsor
- Sun Yat-sen University
HER2-positive Gastric Cancer, Metastatic Gastric Cancer
First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)
This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive…
- Conditions
- HER2-positive Gastric Cancer, Metastatic Gastric Cancer, Unresectable Gastric Carcinoma
- Trial name
- NCT06730373
- Testing
- Disitamab Vedotin, Sintilimab, S-1
- Where
- 20 sites in China
- Volunteers
- 110 people
- Sponsor
- Qilu Hospital of Shandong University
Extensive-stage Small Cell Lung Cancer (ES-SCLC), Extensive Stage Lung Small Cell Cancer
Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
This is a single arm, multi-center clinical trial. The goal of this clinical trial is to evaluate the efficacy, safety and biomarkers of Tafolecimab combined with Sintilimab and Chemotherapy as first-line treatment for patients…
- Conditions
- Extensive-stage Small Cell Lung Cancer (ES-SCLC), Extensive Stage Lung Small Cell Cancer, Extensive-Stage Small-Cell Lung Cancer, Extensive Disease Small Cell Lung Cancer
- Trial name
- STAR-SCLC (NCT07061535)
- Testing
- Tafolecimab, Sintilimab (approved), Etoposide
- Where
- 5 sites in China
- Volunteers
- 40 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Stomach Neoplasms, Gastric Cancer
A Phase II Study of Irinotecan Liposome Plus Fruquintinib and Sintilimab in Second-Line PD-L1-Positive Advanced Gastric Cancer
English Translation (for ClinicalTrials.gov Patient-Friendly Summary): This is a Phase II clinical trial for patients with advanced gastric cancer (stomach cancer).
- Trial name
- NCT07819019
- Testing
- Fruquintinib, Sintilimab, Irinotecan Hydrochloride Liposome Injection (II)
- Volunteers
- 20 people
- Sponsor
- Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Hepatocellular Carcinoma
ZG005 Plus Bevacizumab vs Sintilimab Plus Bevacizumab as First-Line Therapy for Advanced Hepatocellular
The purpose of the study is to evaluate the efficacy of ZG005 combined with bevacizumab compared with sintilimab combined with bevacizumab in the first-line treatment of participants with advanced HCC
- Trial name
- NCT07813572
- Testing
- ZG005 for Injection, Bevacizumab ( Avastin), Sintilimab
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Chronic Hepatitis B
Sequential PD-1 Antibody and Pegylated Interferon Therapy for Nucleos(t)Ide Analogue-suppressed Chronic Hepatitis B
This is a prospective, multicenter, randomized, open-label controlled clinical trial designed to evaluate the efficacy and safety of a sequential treatment strategy incorporating a PD-1 antibody and pegylated interferon-α…
- Trial name
- NCT07809165
- Testing
- Sintilimab, Pegylated Interferon-α 2b, Nucleos(t)ide Analogues
- Where
- 4 sites in China
- Volunteers
- 60 people
- Sponsor
- Beijing 302 Hospital
Mucosal Melanoma, PD-L1 Positive
Sintilimab Combined With Chemotherapy for Adjuvant Treatment of Mucosal Melanoma After Surgery
Melanoma has emerged as the fastest-growing malignancy in recent years, with incidence and mortality rates among both men and women in East Asian countries exceeding the Asian average.
- Trial name
- NCT07400302
- Testing
- Sintilimab, Dacarbazine or Temozolomide, Cisplatin
- Where
- China
- Volunteers
- 220 people
- Sponsor
- The First Hospital of Jilin University
Esophageal Squamous Cell Carcinoma
Paclitaxel Polymeric Micelles and Cisplatin Plus Sintilimab as Neoadjuvant Therapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
Locally advanced Esophageal Squamous Cell Carcinoma (ESCC) has poor prognosis with standard therapies. Neoadjuvant immunochemotherapy improves pathological response rates, but optimal regimens remain undefined.
- Trial name
- NCT07799077
- Testing
- Paclitaxel polymer micelles for injection and cisplatin combined with sintilimab
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Hebei Medical University Fourth Hospital
Biliary Tract Cancer
Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT for Locally Advanced Biliary Tract Cancer
This is a prospective, single-arm, exploratory interventional study designed to evaluate the efficacy and safety of liposomal irinotecan (II) plus fluorouracil/leucovorin (5-FU/LV) and sintilimab with sequential stereotactic body…
- Trial name
- NCT07797816
- Testing
- Irinotecan Hydrochloride Liposome Injection (II), Fluorouracil, Leucovorin
- Where
- China
- Volunteers
- 31 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Advanced HBV-Related Hepatocellular Carcinoma
A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of BRII-5395 in Combination With Sintilimab and Bevacizumab in Advanced Hepatitis B Virus Related Hepatocellular Carcinoma
This early phase (Phase 1) study will evaluate BRII 5395, administered in combination with two approved anticancer agents, sintilimab and bevacizumab, in patients with advanced liver cancer caused by chronic hepatitis B virus…
- Trial name
- NCT07557251
- Testing
- BRII-5395, Sintilimab, Bevacizumab
- Where
- China
- Volunteers
- 21 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Liver Cancer
A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Targeted Therapy and a PD-1 Inhibitor in Patients With Postoperative Hepatocellular Carcinoma and Microvascular Invasion
A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined with Targeted Therapy and a PD-1 Inhibitor in Patients with Postoperative Hepatocellular Carcinoma…
- Trial name
- NCT07790419
- Testing
- HAIC, Donafenib + lenvatinib+apatinib, Sintilimab+camrelizumab+tislelizumab
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Zhai Wenlong
Advanced Solid Tumors
Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Advanced Solid Tumors
This is a multicenter, open label, phase I trial to evaluate the safety and tolerability, pharmacokinetic/ pharmacodynamic characteristics and to assess the preliminary efficacy of SIM0348 as monotherapy or with sintilimab in…
- Trial name
- NCT05718219
- Testing
- SIM0348, SIM0348 + Sintilimab
- Where
- China
- Volunteers
- 49 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Locally Advanced Head and Neck Squamous Cell Carcinoma
Sintilimab Plus Hypofractionated Radiotherapy Followed by Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Most patients with head and neck squamous cell carcinoma (HNSCC) are diagnosed with locally advanced disease. While cisplatin-based chemoradiotherapy remains the standard-of-care treatment for this patient population, it is still…
- Trial name
- NCT07781072
- Testing
- Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and Sintilimab
- Where
- China
- Volunteers
- 27 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Rectal Cancer
Radiotherapy Combined With Capeox Chemotherapy, Sintilimab and Suvemcitug in Locally Advanced pMMR Rectal Cancer:a Prospective Clinical Trial
This study is a prospective, single-arm clinical trial with a dose-reduction design, which is expected to enrol 18 patients with locally advanced rectal cancer with pMMR status.
- Trial name
- RADIANT (NCT07774754)
- Testing
- Drug：sintilimab, Drug：Capecitabine, Drug：Suvemcitug
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Sun Yat-sen University
Hepatocellular Carcinoma Non-resectable
TACE Combined With Sintilimab and Bevacizumab for Unresectable HCC
This study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization (TACE) combined with sintilimab and bevacizumab in patients with unresectable intermediate or advanced hepatocellular carcinoma (HCC).
- Trial name
- NCT04592029
- Testing
- TACE combined with sintilimab and bevacizumab
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Second Affiliated Hospital of Guangzhou Medical University
Gastric Cancer
IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer
This is a Single-arm, Open-label, Phase 1b/2 Study of IBI343 Combined with Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or…
- Trial name
- NCT07025889
- Testing
- IBI343, Sintilimab, Oxaliplatin
- Where
- China
- Volunteers
- 55 people
- Sponsor
- Ruijin Hospital
Natural Killer/T-cell Lymphoma
GELAD-Based Response-Adapted Treatment for Early-Stage Extranodal NK/T-Cell Lymphoma
This prospective, multicenter study evaluates a response-adapted treatment strategy for previously untreated patients with early-stage extranodal NK/T-cell lymphoma of the upper aerodigestive tract.
- Trial name
- NCT07768943
- Testing
- Gemcitabine (GEM), Etoposide Injection, Dexamethasone
- Where
- China
- Volunteers
- 620 people
- Sponsor
- Fudan University
Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
This is a Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined with Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal…
- Trial name
- NCT07643623
- Testing
- tegafur, Gimeracil and Oteracil Potassium Capsules, Sintilimab, Ipilimumab N01
- Where
- China
- Volunteers
- 720 people
- Sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
HCC - Hepatocellular Carcinoma
Evaluate the Safety and Efficacy of Combination Therapy With SYS6090 Injection for Hepatocellular Carcinoma
This is an open-label, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of combination therapy with SYS6090 Injection in participants with hepatocellular carcinoma (HCC).
- Trial name
- NCT07761286
- Testing
- SYS6090 Injection + Bevacizumab Injection, SYS6090 Injection +SYS6043 Injection +Bevacizumab Injection, Bevacizumab Injection + Sintilimab Injection
- Where
- China
- Volunteers
- 288 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.