Clinical trials: Neoadjuvant Therapy in Rectal Cancer, active
Locally Advanced Rectal Adenocarcinoma
Study Evaluating Two Treatment Strategies for Rectal Cancer in Patients ≥75 Years Old
The primary objective of the NACRE-2 trial is to assess whether the addition of chemotherapy after short-course radiotherapy is more effective than short-course radiotherapy alone in elderly patients with locally advanced rectal…
- Trial name
- NACRE-2 (NCT07118800)
- Testing
- FOLFOX4s, Short Course Radiotherapy
- Volunteers
- 160 people
- Sponsor
- UNICANCER
Rectal Neoplasms, Rectal Cancer
A Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Participants With Locally Advanced Rectal Cancer
This study will evaluate the efficacy and safety of atezolizumab plus tiragolumab or atezolizumab alone following neoadjuvant chemoradiotherapy (nCRT) in participants with locally advanced rectal cancer (LARC).
- Trial name
- NCT05009069
- Testing
- Radiotherapy, Capecitabine, Fluorouracil
- Where
- 5 sites in China
- Volunteers
- 58 people
- Sponsor
- Hoffmann-La Roche
Rectal Cancer, Adenocarcinoma of the Rectum
A Study of Response to Standard Treatment Before Surgery in People With Rectal Cancer
The purpose of the study is to learn more about how the body responds to standard treatment (chemoradiation and chemotherapy). The study will use the results of testing down on participants' blook, tissue, and scans to learn more…
- Trial name
- NCT06637462
- Testing
- Endoscopy
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Rectal Cancer, Neoadjuvant Therapy
Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer
Background There is currently no reliable means to restage rectal cancers after neoadjuvant chemoradiation. There are still no reliable methods to identify patients with pCR before radical surgery.
- Conditions
- Rectal Cancer, Neoadjuvant Therapy, Complete Remission, Metastasis
- Trial name
- BIOPSY (NCT04743102)
- Testing
- multi-points and full-thickness Biopsy, traditional cCR
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Beijing Chao Yang Hospital
Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX
Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer
Phase II, Multicenter, Open-label, Randomized Study evaluating neoadjuvant chemotherapy (FOLFOX4) in patients with stage II and III colorectal cancer with standard chemoradiation Defined by Magnetic Resonance Imaging
- Trial name
- RECTUM2015 (NCT05378919)
- Testing
- Radiotherapy 50 Gy, Fluorouracil/folic acid, Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4)
- Where
- Lithuania
- Volunteers
- 250 people
- Sponsor
- Lithuanian University of Health Sciences
Rectal Neoplasms
Short-course Radiotherapy or Long-course Chemoradiation Followed by mFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer
Given the growing focus on preserving organ function and the utilization of neoadjuvant therapy, it is important to investigate and enhance the application of comprehensive neoadjuvant therapy in low rectal cancer.
- Trial name
- NCT06417476
- Testing
- Short-course radiotherapy, Irinotecan, Oxaliplatin
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Pei-Rong Ding
Rectal Cancer
Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer
Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment).
- Trial name
- TNT-RECORD (NCT05883800)
- Testing
- On-couch adaptive radiotherapy
- Where
- Norway
- Volunteers
- 61 people
- Sponsor
- Haukeland University Hospital
Locally Advanced Rectal Cancer
A Prospective, Single-center, Phase II Study of Neoadjuvant Serplulimab Plus XELOX and Bevacizumab in Locally Advanced Rectal Cancer
The purpose of this clinical trial is to understand the treatment effects of serplulimab combined with XELOX and bevacizumab as neoadjuvant therapy for locally advanced rectal cancer. 1.
- Trial name
- NCT07854964
- Testing
- Serplulimab, Bevacizumab, Oxaliplatin
- Volunteers
- 48 people
- Sponsor
- Tang-Du Hospital
Rectal Adenocarcinoma
Neoadjuvant Radiotherapy vs Upfront Surgery in Locally Advanced Proximal Rectal Cancer
The PRELUDE Study: A Prospective Cohort Study Comparing Neoadjuvant Radiotherapy Followed by Total Mesorectal Excision Versus Upfront Surgery in Patients with Locally Advanced Proximal Rectal Cancer The PRELUDE Study is a…
- Trial name
- PRELUDE (NCT07802197)
- Testing
- radiotherapy, surgery
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Istanbul University
Lung Cancer Non-small Cell, Colorectal Cancer
Multimodal Liquid-Biopsy Omics Biomarkers of Treatment Response in Breast Cancer
This single-center cohort study integrates humoral immune response profiling (Phage ImmunoPrecipitation Sequencing, PhIP-seq) with circulating cell-free DNA (cfDNA) genomic and epigenomic features, exosome transcriptomics, and…
- Conditions
- Lung Cancer Non-small Cell, Colorectal Cancer, Stomach Cancer, Hepatocellular Carcinoma
- Trial name
- NCT07880106
- Where
- China
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locally Advanced Rectal Cancer (LARC), Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET)
This study is a prospective, multi-cohort clinical trial designed to evaluate the preliminary efficacy and safety of zanidatamab in combination with tislelizumab and chemotherapy/radiotherapy for patients with HER2-positive…
- Conditions
- Locally Advanced Rectal Cancer (LARC), Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma, Metastatic Colorectal Cancer (mCRC), Neoadjuvant Therapy
- Trial name
- NCT07243938
- Testing
- short-course radiotherapy, Zanidatamab, Tisleizumab(BGB-A317)
- Volunteers
- 70 people
- Sponsor
- Tao Zhang
Colorectal Cancer
Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer
The purpose of this study is to evaluate the safety and clinical activity of combining cemiplimab, cemiplimab/fianlimab, or cemiplimab/REGN7075 with capecitabine/oxaliplatin (CAPOX) for the neoadjuvant treatment of patients with…
- Trial name
- NCT07281768
- Testing
- Oxaliplatin, Capecitabine, Cemiplimab
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Early Rectal Cancer, Stage I Rectal Cancer
RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer
This is a multi-site, prospective, non-randomized phase 2 study evaluating neoadjuvant botensilimab in combination with balstilimab for patients with microsatellite stable (MSS) / mismatch repair proficient (MMRp) early rectal…
- Conditions
- Early Rectal Cancer, Stage I Rectal Cancer, Microsatellite Stable Rectal Carcinoma
- Trial name
- RECTIFY-1 (NCT07735624)
- Testing
- Botensilimab, Balstilimab
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- Dana-Farber Cancer Institute
Rectal Cancer
Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC
The study is a multicenter, open-label, phase II clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR)) of…
- Trial name
- NCT06542588
- Testing
- HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody)
- Where
- 3 sites in China
- Volunteers
- 29 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Rectal Neoplasms
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
This prospective observational study characterises the tumour immune microenvironment and microbial ecology of locally advanced rectal cancer before and during neoadjuvant therapy.
- Trial name
- NCT07920770
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Fujian Medical University Union Hospital
Rectal Cancers
Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adebrelimab in pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Randomized, Phase II Clinical Trial
To explore the efficacy and safety of radiotherapy combined with Adebrelimab and NALIRIFOX in patients with pMMR/MSS locally advanced rectal cancer
- Trial name
- NCT07622771
- Testing
- Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX, Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX
- Where
- China
- Volunteers
- 84 people
- Sponsor
- Sun Yat-sen University
Rectal Cancer, Advanced Solid Tumor
Neoadjuvant Short-Course Radiotherapy Followed by CAPOX Plus PD-1 Antibody and IL-2 in Locally Advanced Rectal Cancer (PRIDE01)
A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy Followed by Sequential Immunotherapy with CAPOX Combined with PD-1 antibody and IL-2 for Locally Advanced Rectal Cancer
- Trial name
- NCT06577194
- Testing
- Sintilimab + IL-2 Combined with CAPOX, Short-course radiotherapy
- Where
- China
- Volunteers
- 35 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
LOCALLY ADVANCED RECTAL CANCER
Organ Preservation in Locally Advanced Rectal Cancer
PRONAR trial aims to assess if treatment with organ preservation in stage II and III rectal cancer after a complete or almost complete response to neoadjuvant treatment is feasible and safe in our environment.
- Trial name
- PRONAR (NCT03064646)
- Testing
- Organ Preservation
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Locally Advanced Colorectal Cancer
Efficacy of the Use of Neoadjuvant With/Without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer
The main objective of this randomized and controlled trial is to determine whether the use of a proactive strategy, systemic neoadjuvant treatment (FOLFOX) with or without hyperthermic intraperitoneal chemoterapy (HIPEC) with…
- Trial name
- FOXHIPECT4 (NCT06783491)
- Testing
- Mitomycin (MM), FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin), Cytoreductive surgery
- Where
- Spain
- Volunteers
- 1,083 people
- Sponsor
- Maimónides Biomedical Research Institute of Córdoba
Colorectal Cancer
Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer
Rectal cancer represents the most complex area of multidisciplinary treatment in bowel surgery. In 2017, there were 1221 new rectal cancers in Finland.
- Trial name
- SYNCOPE (NCT04842006)
- Testing
- Total neoadjuvant therapy (TNT), Minimal residual disease (MRD), Long radiation therapy
- Where
- 2 sites in Finland
- Volunteers
- 93 people
- Sponsor
- Helsinki University Central Hospital