Clinical trials: Locally Advanced Rectal Cancer
Locally Advanced Rectal Carcinoma
Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer
The aim of this clinical trial is to compare triplet induction therapy (FOLFOXIRI) with doublet induction therapy (CAPOX/FOLFOX), followed by chemoradiotherapy and either surgery or a watch-and-wait approach, in patients with…
- Trial name
- MEND-IT II (NCT07472868)
- Testing
- FOLFOXIRI, CAPOX, FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
- Where
- 20 sites in Netherlands
- Volunteers
- 394 people
- Sponsor
- J. W. A. Burger
Locally Advanced Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8
Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer
This phase II trial investigates the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally…
- Conditions
- Locally Advanced Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8
- Trial name
- NCT04751370
- Testing
- Computed Tomography, Ipilimumab, Magnetic Resonance Imaging
- Where
- 213 sites in United States
- Volunteers
- 31 people
- Sponsor
- National Cancer Institute (NCI)
Localized Prostate Carcinoma, Locally Advanced Cervical Carcinoma
Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers
This phase II trial studies how well time-restricted eating works in reducing side effects of radiation or chemoradiation side effects when compared to nutritional counseling among patients with prostate, cervical, and rectal…
- Conditions
- Localized Prostate Carcinoma, Locally Advanced Cervical Carcinoma, Locally Advanced Rectal Carcinoma, Malignant Solid Neoplasm
- Trial name
- NCT05722288
- Testing
- Biospecimen Collection, Informational Intervention, Quality-of-Life Assessment
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- City of Hope Medical Center
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 Cancer (LARC)
Neoadjuvant Chemoradiotherapy Plus PD-1 Blockade ± CTLA-4 Blockade for Low/Intermediate-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 low- or intermediate-risk, locally…
- Trial name
- NCT07879599
- Testing
- Ipilimumab & Sintilimab, Sintilimab
- Volunteers
- 120 people
- Sponsor
- Yao Hongwei
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
Locally Advanced Rectal Cancer
Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer
To explore the complete response (CR) rate of modified short-course radiotherapy plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer.
- Trial name
- NCT07469306
- Testing
- Modified Short-course radiotherapy, Long-course radiotherapy, Oxaliplatin
- Where
- 3 sites in China
- Volunteers
- 130 people
- Sponsor
- Fujian Cancer Hospital
Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation and Continuing Response
This phase II/III trial compares the effect of usual treatment approach alone (FOLFOX or CAPOX after chemoradiation) with using FOLFIRINOX after chemoradiation in patients with stage II-III rectal cancer.
- Conditions
- Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Locally Advanced Rectal Adenocarcinoma
- Trial name
- JANUS (NCT05610163)
- Testing
- Capecitabine, 5-fluorouracil, Leucovorin calcium
- Where
- 685 sites in United States, Puerto Rico
- Volunteers
- 760 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Locally Advanced Rectal Carcinoma
Radiological Markers in Locally Advanced Rectal Cancer
The goal of this observational study is to evaluate the prognostic significance of radiological markers, including the Likert Score derived from diffusion-weighted MRI (DWI), in patients with locally advanced rectal cancer (LARC)…
- Trial name
- LARC (NCT06843655)
- Where
- Italy
- Volunteers
- 179 people
- Sponsor
- IRCCS San Raffaele
Locally Advanced Rectal Adenocarcinoma, Metastatic Rectal Adenocarcinoma
Circulating Tumor Cells in Patients With Locally Advanced Rectal Cancer
This study looks at the level of circulating tumor elements (cancer cells or DNA pieces floating in the blood) and how it may be related to how the tumor responds to standard treatment in patients with rectal cancer that has…
- Conditions
- Locally Advanced Rectal Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Rectosigmoid Adenocarcinoma, Recurrent Rectal Adenocarcinoma
- Trial name
- NCT02874885
- Testing
- Biospecimen Collection
- Where
- United States
- Volunteers
- 341 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
Locally Advanced Rectal Cancer (LARC)
NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer
The FORTRESS trial (NG-350A-03) is an open-label, single-arm, and multicentre trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with locally advanced rectal cancer (LARC) and at least one risk factor…
- Trial name
- FORTRESS (NCT06459869)
- Testing
- NG-350A IV administration, Capecitabine oral administration, Radiotherapy
- Where
- 7 sites in United States, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Akamis Bio
Locally Advanced Rectal Cancer (LARC), 5-12cm to Anal Verge
Iparomlimab and Tuvonralimab Combined With Chemotherapy and Bevacizumab as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
This study aims to observe and evaluate the efficacy and safety of Iparomlimab and Tuvonralimab（QL-1706） combined with chemotherapy and bevacizumab ± radiotherapy as neoadjuvant therapy in patients with locally advanced rectal…
- Trial name
- IT-CABLE (NCT07769853)
- Testing
- Iparomlimab and Tuvonralimab（QL-1706）combined with Chemotherapy and Bevacizumab
- Volunteers
- 56 people
- Sponsor
- Zhejiang University
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
pMMR/MSS, Locally Advanced Rectal Carcinoma
16-Hour Fasting Plus Serplulimab and CAPEOX as Neoadjuvant Therapy in pMMR/MSS Advanced Mid-to-Low Rectal Cancer
Although standard neoadjuvant chemoradiotherapy (nCRT) for locally advanced rectal cancer (LARC) effectively reduces local recurrence, radiotherapy-related toxicities and surgical complications severely impair patients' quality…
- Conditions
- pMMR/MSS, Locally Advanced Rectal Carcinoma, Fasting, Intermittent
- Trial name
- NCT07779694
- Testing
- 16-Hour Fasting, Serplulimab + chemotherapy
- Volunteers
- 51 people
- Sponsor
- Zhejiang University
Locally Advanced Malignant Neoplasm, Rectal Carcinoma
Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma
Locally advanced rectal carcinoma raise the issue of both the oncological control, local and general, and the therapeutic morbidity.
- Trial name
- GRECCAR14 (NCT04749108)
- Testing
- Induction chemotherapy - modified FOLFIRINOX regimen, Early tumor response evaluation by MRI volumetry, Radiochemotherapy Cap 50
- Where
- 30 sites in France
- Volunteers
- 1,075 people
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
Locally Advanced Rectal Cancer
CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Microsatellite Stable Locally Advanced Rectal Cancer
This prospective, single-arm study aims to investigate the efficacy and safety of pembrolizumab plus bevacizumab and chemotherapy as neoadjuvant treatment in pMMR/MSS locally advanced rectal cancer patients
- Trial name
- COBP (NCT05585814)
- Testing
- Capecitabine, Oxaliplatin, Bevacizumab
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shanghai Changzheng Hospital
Locally Advanced Rectal Carcinoma, Neoadjuvant Treatment
Longitudinal Multimodal Response Assessment During Neoadjuvant Treatment of Rectal Cancer
This pilot study aims to trial multimodal early response assessment to enable therapy adaptions in the context of non-operative therapy strategies of locally advanced rectal cancer (LARC) for development of a non-invasive…
- Conditions
- Locally Advanced Rectal Carcinoma, Neoadjuvant Treatment, Radiotherapy, Adaptive Treatment
- Trial name
- PRIMO (NCT05524012)
- Testing
- Blood sample, MRI scan
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Jena University Hospital
Rectal Adenocarcinoma, Rectal Cancer
ctDNA-Informed Management of Early-Stage Rectal Cancer
This is a phase 2 pragmatic study to examine the utility of ctDNA-informed treatment management for participants with early-stage rectal cancer using the Signatera Genome assay.
- Conditions
- Rectal Adenocarcinoma, Rectal Cancer, Early-stage Rectal Cancer, Locally Advanced Rectal Adenocarcinoma
- Trial name
- ULTIMATE (NCT07209215)
- Testing
- Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of California, Davis
Locally Advanced Rectal Cancer, Older People
Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer
The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal…
- Trial name
- SHAPERS (NCT06052332)
- Testing
- Short course radiotherapy, Adjuvant chemotherapy (optional), Total mesorectal excision
- Where
- 19 sites in Belgium
- Volunteers
- 230 people
- Sponsor
- Jules Bordet Institute
Locally Advanced Rectal Cancer
Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I)
The purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer.
- Trial name
- NCT07057089
- Testing
- Capecitabine, Camrelizumab, CAPOX
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Hebei Medical University Fourth Hospital