Clinical trials: Locally Advanced Rectal Cancer (LARC)
Rectal Neoplasms, Adenocarcinoma
Preoperative Chemoradiation Followed by Chemotherapy for Locally Advanced Rectal Cancer
The current standard treatment of locally advanced rectal cancer (clinical stage II or III) is preoperative radiation with chemotherapy (CRT) followed by surgery.
- Trial name
- PREPARE (NCT01952951)
- Testing
- Capecitabine Oxaliplatin, pelvic radiation capecitabine 5-fluorouracil
- Where
- 7 sites in South Korea
- Volunteers
- 110 people
- Sponsor
- National Cancer Center, Korea
Locally Advanced Rectal Cancer (LARC)
Short-Course Online Adaptive Radiotherapy Combined With Chemotherapy, Targeted Therapy and Immunotherapy as Total Neoadjuvant Therapy (TNT) for Locally Advanced Rectal Cancer
Standard treatment for patients with proficient mismatch repair (pMMR) / microsatellite stable (MSS) locally advanced rectal cancer (LARC) consists primarily of neoadjuvant chemoradiotherapy followed by radical surgery.
- Trial name
- NCT07581626
- Testing
- SCRT+targeted therapy+immunotherapy+chemotherapy
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Chinese PLA General Hospital
Rectal Cancer Patients, Locally Advanced Rectal Cancer (LARC)
NeoCSR-Omics Trial: CAPOX + Serplulimab Before vs. After Short-course RT in LARC
This is a prospective, randomized, multicenter phase II trial evaluating neoadjuvant CAPOX chemotherapy combined with the PD-1 inhibitor serplulimab administered either before or after short-course radiotherapy (SCRT) in patients…
- Trial name
- NeoCSR-Omics (NCT07898865)
- Testing
- radiotherapy, CAPOX (oxaliplatin/capecitabine), Serplulimab
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Chongqing University Cancer Hospital
Colorectal Cancer
SCRT Followed by Camrelizumab Combined With Fluzoparib and Chemotherapy as Neoadjuvant Therapy for LARC
To explore the safety and efficacy of neoadjuvant therapy for locally advanced rectal cancer with short course radiotherapy followed by camrelizumab combined with fluzoparib and chemotherapy
- Trial name
- NCT06516445
- Testing
- SCRT, Camrelizumab, Fluzoparib
- Where
- China
- Volunteers
- 33 people
- Sponsor
- Huazhong University of Science and Technology
Locally Advanced Rectal Cancer (LARC)
A Study to Evaluate a Chemotherapy Treatment Followed by Chemo and Radiotherapy in Patients With Rectal Cancer
This is an exploratory, open-label, single arm, non-randomized, multicenter, phase II clinical trial to determine the efficacy and clinical complete response rate in patients with rectal cancer and tumor preoperative evaluation…
- Trial name
- NCT04009876
- Testing
- nal-IRI, Surgical resection, Watch-and-wait
- Where
- 4 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Fundación de investigación HM
Locally Advanced Rectal Cancer (LARC)
SCRT Combined With Chemotherapy and Iparomlimab and Tuvonralimab in MSS or pMMR Patients With Locally Advanced Rectal Cancer
Colorectal cancer ranks as the third most prevalent malignancy worldwide and the second leading cause of cancer-related mortality.
- Trial name
- NCT06864013
- Testing
- Experimental, Control
- Where
- China
- Volunteers
- 116 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Locally Advanced Rectal Cancer (LARC)
AI-Based Prediction of Pathological Response in Rectal Cancer Patients Receiving Total Neoadjuvant Therapy
This study aims to better understand how body composition, inflammation, and nutrition affect how rectal cancer responds to treatment.
- Trial name
- CINR-AI (NCT07049627)
- Testing
- Total Neoadjuvant Therapy (TNT)
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 93 people
- Sponsor
- Ankara Etlik City Hospital
Locally Advanced Rectal Cancer (LARC)
XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients
This is a phase II, multicenter, randomized (2:1) controlled, clinical trial to evaluate the preliminary efficacy and safety of consolidation chemotherapy (XELOX) plus dostarlimab after standard long-course CRT (ARM A) compared…
- Trial name
- IMMUNOSTAR (NCT07381777)
- Testing
- XELOX (Capecitabine and Oxaliplatin), Dostarlimab
- Where
- 30 sites in Italy
- Volunteers
- 270 people
- Sponsor
- Gruppo Oncologico Italiano di Ricerca Clinica
Rectal Cancer Patients
Radiotherapy Plus Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as Neoadjuvant Therapy for pMMR/MSS LARC.
This study is a multicenter, prospective, randomized, double-arm, Phase II clinical trial designed to evaluate the efficacy of short-term radiotherapy combined with Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as…
- Trial name
- NCT06911684
- Testing
- lparomlimab and Tuvonralimab Injection and regorafenib and CPAOX and short-course radiotherapy
- Where
- China
- Volunteers
- 88 people
- Sponsor
- Sun Yat-sen University
Locally Advanced Rectal Cancer (LARC)
Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer
This is an observational, retrospective-prospective, multicentre trial enrolling all patients included in the AIFA monitoring registry of Dostarlimab for the indication in rectal cancer.
- Trial name
- RW-NEDOS (NCT07269249)
- Testing
- Dostarlimab
- Where
- 2 sites in Italy
- Volunteers
- 50 people
- Sponsor
- National Cancer Institute, Naples
Locally Advanced Rectal Cancer (LARC)
Optimizing Immunotherapy Combined With Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer
This study explores the key clinical issues in the field of neoadjuvant therapy for locally advanced rectal cancer. There are three core problems with the currently recommended total neoadjuvant therapy (TNT) in the guidelines…
- Trial name
- STELLARIII (NCT07040098)
- Testing
- Sintilimab, Short-course radiotherapy, Long-course concurrent chemoradiotherapy
- Where
- 2 sites in China
- Volunteers
- 228 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locally Advanced Rectal Cancer (LARC), Mismatch Repair-Proficient (pMMR) Rectal Cancer
QL1706 With Short-Course Radiotherapy and Chemotherapy for MSS Rectal Cancer
This is a multicenter, prospective, phase II study evaluating total neoadjuvant therapy (TNT) consisting of short-course radiotherapy (SCRT; 5×5 Gy) followed by QL1706 (a bifunctional MabPair antibody targeting PD-1 and CTLA-4…
- Conditions
- Locally Advanced Rectal Cancer (LARC), Mismatch Repair-Proficient (pMMR) Rectal Cancer, Non-metastatic Rectal Cancer
- Trial name
- NCT07175636
- Testing
- Drug: QL1706 Drug: mFOLFOX6 Radiation: Short-Course Radiotherapy (SCRT)
- Volunteers
- 66 people
- Sponsor
- Sun Yat-sen University
Rectal Cancer Patients, Obesity &Amp; Overweight
Evaluating the Impact of GLP-1 Receptor Agonists With Total Neoadjuvant Therapy in Rectal Cancer
The goal of this clinical trial is to see if adding a weight loss medication (GLP-1 receptor drug) to patients with an increased BMI receiving treatment for rectal cancer prior to surgery (total neoadjuvant chemoradiotherapy)…
- Conditions
- Rectal Cancer Patients, Obesity &Amp; Overweight, Locally Advanced Rectal Cancer (LARC), Total Neoadjuvant Therapy
- Trial name
- NCT07314528
- Testing
- GLP-1 receptor agonist, Total neoadjuvant therapy (TNT)
- Volunteers
- 42 people
- Sponsor
- St. James's Hospital, Ireland
Locally Advanced Rectal Cancer
Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer
This is a phase II/III, multi-center, open-label, 3-arm, randomized controlled trial assessing the efficacy and safety of neoadjuvant long-course chemoradiation combined with Tislelizumab (PD-1 inhibitor) and subsequent TME…
- Trial name
- NCT05245474
- Testing
- Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)
- Where
- 8 sites in China
- Volunteers
- 186 people
- Sponsor
- Beijing Friendship Hospital
Locally Advanced Rectal Cancer (LARC)
Neoadjuvant Chemoradiotherapy Plus PD-1 Blockade ± CTLA-4 Blockade for High-Risk Locally Advanced Rectal Cancer (pMMR/MSS): A National Multicenter, Prospective, Randomized Controlled Trial
The goal of this clinical trial is to learn whether adding ipilimumab N01 to standard pre-surgery treatment with radiation, chemotherapy, and sintilimab can improve outcomes for people with high-risk, locally advanced rectal…
- Trial name
- NCT07879586
- Testing
- Ipilimumab & Sintilimab, Sintilimab
- Volunteers
- 120 people
- Sponsor
- Yao Hongwei
Locally Advanced Rectal Adenocarcinoma, Neoadjuvant Chemoradiation
Yang et al. Anti-PD-1/CTLA-4 Dual Immunotherapy for LARC
This is a prospective, multicenter, randomized controlled trial aimed at comparing different radiotherapy fractionation regimens combined with sequential dual immunotherapy versus traditional chemoradiotherapy in neoadjuvant…
- Conditions
- Locally Advanced Rectal Adenocarcinoma, Neoadjuvant Chemoradiation, Neoadjuvant Immunotherapy
- Trial name
- RADICAL (NCT07596290)
- Testing
- Short-course radiotherapy, Long-course radiotherapy, Immunotherapy
- Volunteers
- 342 people
- Sponsor
- Beijing Friendship Hospital
Locally Advanced Rectal Cancer (LARC)
Serine/Glycine-Restricted Diet With Chemoradiotherapy for Rectal Cancer
This is a Phase Ib/II seamless, open-label, randomized controlled trial evaluating the safety and efficacy of a serine/glycine-restricted diet combined with neoadjuvant chemoradiotherapy and immunotherapy in patients with locally…
- Trial name
- SG-RCT (NCT07811076)
- Testing
- Serine/Glycine-Restricted Diet, CAPOX Chemotherapy, PD-1 Inhibitor
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Xuelei Ma MD
Rectal Cancer Patients, Rectal Cancer Stage II
Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression
This study is a prospective, multicenter, open-label, randomized controlled Phase II clinical trial enrolling patients with locally advanced rectal cancer who tested positive for YWHAB (tyrosine 3-monooxygenase/tryptophan…
- Conditions
- Rectal Cancer Patients, Rectal Cancer Stage II, Rectal Cancer Stage III
- Trial name
- NCT07176182
- Testing
- mFOLFOX regimen combined with Citrus Flavone Tablets (Alvenor) neoadjuvant treatment group, mFOLFOX regimen neoadjuvant therapy group
- Where
- China
- Volunteers
- 236 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Rectal Cancer
Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer
The purpose of this study is to evaluate the safety and clinical activity of combining DCSZ11 with radiation and capecitabine/oxaliplatin (CAPOX) for the neoadjuvant treatment of patients with mismatch repair proficient (pMMR)…
- Trial name
- NCT07580339
- Testing
- DCSZ11, Radiation, Capecitabine
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Rectal Adenocarcinoma, High-Risk Cancer
NCT + PD1 + Ketogenic Diet and/or Vitamin C for LARC
To explore the efficacy and safety of adding a ketogenic diet and/or high-dose intravenous vitamin C to neoadjuvant short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with serplulimab in patients with locally…
- Conditions
- Rectal Adenocarcinoma, High-Risk Cancer, MSS
- Trial name
- CRI-KEV (NCT07765667)
- Testing
- Short-Course Radiotherapy, PD-1 monoclonal antibody, mFOLFOX6 regimen
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University