Clinical trials: Neoadjuvant Immunotherapy
Locally Advanced Rectal Cancer
The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSI-H Locally Advanced Rectal Cancer
The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stability-high (MSI-H) locally advanced rectal cancer (LARC).
- Trial name
- NCT04411524
- Testing
- PD-1 antibody, Capecitabine, Irinotecan
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Fudan University
Melanoma, Skin
Omitting Therapeutic Lymph Node Dissection in Patients With Melanoma (Stage 3) and Major Pathological Response in the Index Lymph Node
Rationale: The randomized trial NADINA has demonstrated that neoadjuvant treatment with nivolumab with ipilimumab improves event-free survival (EFS) in patients with macroscopic resectable stage III melanoma.
- Trial name
- OMIT (NCT06754904)
- Testing
- Omitting TLND, Index node procedure
- Where
- Netherlands
- Volunteers
- 213 people
- Sponsor
- D.J. (Dirk) Grünhagen
Glioblastoma, Malignant Glioma
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
This phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive).
- Conditions
- Glioblastoma, Malignant Glioma, Recurrent Glioblastoma, Recurrent Malignant Glioma
- Trial name
- NCT04323046
- Testing
- Nivolumab, Quality-of-Life Assessment, Questionnaire Administration
- Where
- 20 sites in United States, Australia
- Volunteers
- 9 people
- Sponsor
- Sabine Mueller, MD, PhD
Malignant Melanoma Stage III
Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma
This is an international (Australia, Europe, and USA) open-label two-arm randomized phase 3 trial including 420 stage III (≤3 resectable in-transit metastases allowed) cutaneous or unknown primary melanoma patients.
- Trial name
- NADINA (NCT04949113)
- Testing
- Neoadjuvant ipilimumab + nivolumab, Adjuvant nivolumab
- Where
- 24 sites in United States, Australia and 1 more
- Volunteers
- 423 people
- Sponsor
- The Netherlands Cancer Institute
Nasopharyngeal Carcinoma, Nasopharyngeal Cancer
Nivolumab in Children and Adults With Nasopharyngeal Carcinoma
The purpose of this study is to assess whether the addition of the immune checkpoint inhibitor Nivolumab to induction chemotherapy will increase the percentage of patients with a complete response on MRI and PET after 3 cycles of…
- Conditions
- Nasopharyngeal Carcinoma, Nasopharyngeal Cancer, Nasopharyngeal Neoplasms, Nasopharynx Cancer
- Trial name
- NPC-Nivo (NCT06019130)
- Testing
- Nivolumab, Cisplatin, 5-Fluorouracil
- Where
- 31 sites in Germany
- Volunteers
- 57 people
- Sponsor
- German Society for Pediatric Oncology and Hematology GPOH gGmbH
Neoadjuvant Chemoimmunotherapy, Robotic Pulmonary Resection
Downstaging and RATS After Neo-Chemo-IO: Impact on Surgical Outcomes in NSCLC
The goal of this observational study is to learn whether tumor and nodal downstaging after neoadjuvant chemo-immunotherapy is associated with better surgical outcomes in patients with clinical stage IIB-III non-small cell lung…
- Conditions
- Neoadjuvant Chemoimmunotherapy, Robotic Pulmonary Resection, Stage IIB-III NSCLC
- Trial name
- DRAGON-NSCLC (NCT07528066)
- Testing
- Robotic-assisted surgery (RATS)
- Where
- 10 sites in China, France and 1 more
- Volunteers
- 200 people
- Sponsor
- Shanghai Chest Hospital
Gastric (Cardia, Body) Cancer, Stomach Adenocarcinoma
Neoadjuvant Nab-Paclitaxel Plus Oxaliplatin, S-1, and Sintilimab in Early-Onset Resectable Gastric Cancer
This study aims to evaluate the effectiveness and safety of a preoperative treatment (called neoadjuvant therapy) combining four drugs-nab-paclitaxel, oxaliplatin, S-1, and sintilimab-for patients with locally advanced…
- Conditions
- Gastric (Cardia, Body) Cancer, Stomach Adenocarcinoma, Locally Advanced
- Trial name
- YOUNG-NEOS (NCT07018063)
- Testing
- nab-paclitaxel, oxaliplatin, S-1
- Where
- China
- Volunteers
- 35 people
- Sponsor
- zhoujing
Carcinoma, Non-Small-Cell Lung, Neoadjuvant Immunotherapy
Comparison of the Effect of Surgical Resection Based on Lesion Extent Before and After Neoadjuvant Therapy in Patients With Stage II-IIIB Non-Small Cell Lung Cancer: A Single-Center, Real-World, Open-Label Study
This study intends to conduct a prospective, non-interventional study to compare the survival benefits of different surgical resection patterns for patients with non-small cell lung cancer who have achieved partial response (PR)…
- Conditions
- Carcinoma, Non-Small-Cell Lung, Neoadjuvant Immunotherapy, Surgery
- Trial name
- NCT07373899
- Where
- China
- Volunteers
- 354 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Osteosarcoma
Pulmonary Resectable Osteosarcoma Treated by Metastasectomy and Pre-operative Immunotherapy and Stereotactic Body Radiotherapy (PROMIS): a Prospective Clinical Trial
The aim of this study is to evaluate the efficacy and safety of pre-operative concurrent Stereotactic Body Radiotherapy (SBRT) and and programmed cell death protein-1 (PD-1) blockade immunotherapy followed by surgical…
- Trial name
- PROMIS (NCT06114225)
- Testing
- metastasectomy and pre-operative immunotherapy (gemcitabine and penpulimab ) and stereotactic body radiotherapy
- Where
- China
- Volunteers
- 43 people
- Sponsor
- Ruijin Hospital
Colorectal Cancer
Proposal of a Novel Model for Identifying Complete Response in dMMR Colon Cancer Following Neoadjuvant Immunotherapy
A novel evaluation model for identifying complete response following neoadjuvant immune checkpoint inhibitor therapy therapy in patients with dMMR colon cancer was developed to validated its efficacy in two independent cohorts…
- Trial name
- NCT06980350
- Testing
- PD-1 Inhibitors
- Where
- China
- Volunteers
- 156 people
- Sponsor
- Sun Yat-sen University
Non-Small Cell Lung Cancer, Neoadjuvant Therapy
Mechanism of Enhanced Efficacy of Ivonescimab in Neoadjuvant Therapy for Non-Small Cell Lung Cancer
This is an exploratory clinical study focusing on the neoadjuvant treatment of non-small cell lung cancer (NSCLC). The study primarily aims to compare the efficacy and safety of Ivonescimab, a novel PD-1/VEGF bispecific antibody…
- Conditions
- Non-Small Cell Lung Cancer, Neoadjuvant Therapy, PD-1 Inhibitors, Immunotherapy
- Trial name
- NCT07359040
- Testing
- Ivonescimab, PD-1 Inhibitors
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Peking University People's Hospital
Esophageal Squamous Cell Carcinoma, Immunotherapy
Efficacy of Neoadjuvant PD-1 Blockade Plus Chemotherapy for Esophageal Squamous Cell Carcinoma
This study aims to evaluate the efficacy of Camrelizumab plus concurrent chemotherapy as neoadjuvant approach for patients with opearble esophageal squamous cell carcinoma.
- Trial name
- NCT04225364
- Testing
- camrelizumab, Paclitaxel for injection (albumin-bound), Cisplatin
- Where
- China
- Volunteers
- 56 people
- Sponsor
- Guangzhou Institute of Respiratory Disease
Soft Tissue Sarcoma (STS)
Preoperative Radiotherapy and Anlotinib With or Without Penpulimab for Soft Tissue Sarcoma
Soft tissue sarcoma is a rare cancer that often requires surgery combined with radiotherapy. Preoperative radiotherapy can improve the chance of complete tumor removal and limb preservation, but some patients still experience…
- Trial name
- SPARE-04 (NCT07612098)
- Testing
- Anlotinib, Penpulimab, Preoperative Radiotherapy
- Where
- China
- Volunteers
- 274 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Colorectal Cancer Control and Prevention, Colorectal Cancer Recurrent
[68Ga]Ga-GZP PET for Early Response Prediction in Colorectal Cancer During Neoadjuvant Therapy
This diagnostic study investigates the value of 68Ga-NOTA-GZP PET imaging in predicting and evaluating immunotherapy response in malignant tumors by enrolling pathologically confirmed patients scheduled for immunotherapy and…
- Conditions
- Colorectal Cancer Control and Prevention, Colorectal Cancer Recurrent, Colorectal Cancer Metastatic, Colorectal Cancer Screening
- Trial name
- NCT06982053
- Testing
- Received 68Ga-NOTA-GZP PET scanning
- Where
- China
- Volunteers
- 21 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Triple Negative Breast Cancer
De-escalation of Neoadjuvant Chemotherapy Regimens With Immunotherapy Among TNBC
The traditional neoadjuvant therapy for triple negative breast cancer is based on anthracycline, paclitaxel and carboplatin. Nowadays, immunotherapy combined with chemotherapy has become a new standard treatment, which not only…
- Trial name
- NacTNBC (NCT06692725)
- Where
- China
- Volunteers
- 380 people
- Sponsor
- Peking University People's Hospital