Clinical trials: Total Neoadjuvant Therapy
RECTAL NEOPLASMS, Rectal Cancer
Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study
This is an open-label, multi-center, single-arm clinical study. All patients received concurrent chemoradiation therapy (CRT) followed by 4 cycles of tislelizumab combined with CAPOX, then underwent clinical response assessment.
- Trial name
- NCT06390982
- Testing
- Radiotherapy, Tislelizumab, Capecitabine
- Volunteers
- 46 people
- Sponsor
- Fudan University
Rectal Cancer
Total Neoadjuvant mFOLFOX6 Plus Suvemcitug and Enlonstobart With Selective Omission of Pelvic Radiotherapy for High-Risk Mid-Rectal Locally Advanced Rectal Cancer
This is a prospective, multicenter, open-label, single-arm Phase II study designed to evaluate the efficacy and safety of total neoadjuvant mFOLFOX6 combined with suvemcitug and enlonstobart in patients with MRI（Magnetic…
- Trial name
- SPARE (NCT07810114)
- Testing
- mFOLFOX6, Suvemcitug, Enlonstobart
- Where
- China
- Volunteers
- 52 people
- Sponsor
- Fudan University
Rectal Neoplasms
Local Excision in Downstaged Rectal Cancer
Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy.
- Trial name
- GRECCAR 2 (NCT00427375)
- Testing
- local rectal excision, total mesorectal excision
- Where
- 40 sites in France
- Volunteers
- 148 people
- Sponsor
- University Hospital, Bordeaux
Rectal Cancer, Rectal Cancer Stage II
ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer
This is a prospective observational study with three primary objectives: Objective 1: Evaluate the detection rate and changes in circulating tumor DNA (ctDNA) levels in blood samples from colorectal cancer patients before…
- Conditions
- Rectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III
- Trial name
- NCT06589388
- Where
- Vietnam
- Volunteers
- 100 people
- Sponsor
- Gene Solutions
Rectum Cancer
Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients
A phase II clinical trial compared standard TNT (mFolfox6 and CRT) with preoperative chemoradiotherapy (CRT) with neoadjuvant chemotherapy (CT) containing mFolfirinox in patients with locally advanced rectal cancer.
- Trial name
- NCT06812728
- Testing
- mFOLFIRINOX, mFolfox6
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Menoufia University
Neoadjuvant Chemoradiotherapy
Hyperpolarized 13C-MRI and Radiomics in Rectal Cancer
This study is testing new imaging and analysis methods to improve how doctors predict treatment response in rectal cancer patients receiving chemoradiotherapy.
- Trial name
- DNP_RECA (NCT07730541)
- Testing
- Hyperpolarized 13C-MRI (HP 13C-MRI)
- Where
- Taiwan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chang Gung Memorial 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 Cancer
Response Assessment by Circulating Tumor DNA in Patients With Locally Advanced Rectal Cancer
This is a single-arm observational study to determine the feasibility of assessing tumor response utilizing Circulating tumor DNA (ctDNA) in patients of with locally advanced rectal cancer (LARC) undergoing standard-of-care total…
- Trial name
- NCT04670588
- Testing
- Circulating tumor DNA(ctDNA) level measurement
- Where
- United States
- Sponsor
- Medical College of Wisconsin
Locally Advanced Rectal Cancer
Efficacy of NeoThermo-Radio-chemotherapy for LA Rectal Cancer Before Laparoscopic TME: Prospective Phase II Trial
The investigators start this prospective study to evaluate the efficacy of laparoscopic total mesorectal excision after concurrent chemo-radiation therapy with hyperthermia in locally advanced rectal cancer.
- Trial name
- NEOTREAT (NCT02290574)
- Testing
- Hyperthermia with concurrent chemo-radiation therapy
- Where
- South Korea
- Volunteers
- 14 people
- Sponsor
- Samsung Medical Center
Rectum Cancer, Adenocarcinoma
ADAR1 Expression Level in Rectal Cancer
Total neoadjuvant therapy (TNT) is currently the standard treatment for locally/locally advanced rectal cancer due to better response and fewer distant metastases.
- Trial name
- ADAR1TNT (NCT07108348)
- Testing
- Adenosine deaminase acting on RNA1
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Necmettin Erbakan University
Rectal Cancer
Short Course Radiation Therapy Followed by Pre-operative Chemotherapy and Surgery in High-risk Rectal Cancer
Patients with a primary rectal cancer without detectable distant metastasis who after locoregional therapy only, meaning preoperative radio(chemo)therapy plus surgery have at least a 40% risk of not having a CRM negative…
- Trial name
- LARCT-US (NCT03729687)
- Testing
- radiotherapy, capecitabine, oxaliplatin
- Where
- Sweden
- Volunteers
- 280 people
- Sponsor
- Uppsala University
Rectal Cancer, Rectal Adenocarcinoma
SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC
This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (LARC).
- Conditions
- Rectal Cancer, Rectal Adenocarcinoma, Rectal Cancer, Radiotherapy, Rectal Cancer Patients
- Trial name
- NCT07198165
- Testing
- PD-1 inhibitor based immunotherapy
- Where
- China
- Volunteers
- 104 people
- Sponsor
- Ruijin Hospital
Esophagus Cancer
Neoadjuvant Comprehensive Treatment for Unresectable Esophageal Cancer
Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) that is deemed unresectable face a bleak prognosis.
- Trial name
- NEXUS-2 (NCT06430658)
- Testing
- Tislelizumab (BGB-A317) with chemoradiotherapy
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
A Study of Total Neoadjuvant Chemotherapy With FLOT VS Standard Perioperative FLOT in Patients With Gastric or GEJ Cancer
This is a randomized pilot study to evaluate and to compare the completion rates of Total Neoadjuvant chemotherapy with FLOT ( FLOT-TNT) and perioperative chemotherapy with FLOT ( FLOT-POP).
- Trial name
- TOGAR (NCT05567835)
- Testing
- Fluorouracil, Leucovorin, Oxaliplatin
- Where
- 5 sites in United States
- Volunteers
- 3 people
- Sponsor
- Baylor College of Medicine
Rectal Cancer, Total Neoadjuvant Treatment
Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer.
This study hypothesizes that approximately 50% of rectal cancer patients can preserve their rectum using a watch-and-wait strategy if they achieve a complete or near-complete clinical response to total neoadjuvant therapy (TNT).
- Conditions
- Rectal Cancer, Total Neoadjuvant Treatment, Neoadjuvant Therapy, Radiotherapy
- Trial name
- NCT06758830
- Testing
- Radiation Therapy, Chemoradiotherapy, Consolidation Chemotherapy
- Where
- Lithuania
- Volunteers
- 400 people
- Sponsor
- National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
Rectal Cancer
Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer
This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.
- Trial name
- NCT04643366
- Testing
- Chemotherapy, Radiation Therapy
- Where
- 4 sites in United States
- Volunteers
- 64 people
- Sponsor
- Virginia Commonwealth University
Rectal Cancer
A Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
A Phase II Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
- Trial name
- NCT04543695
- Testing
- Concurrent Chemoradiotherapy, XELOX, mFOLFOX
- Where
- China
- Volunteers
- 255 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Rectal Cancer
Total Neoadjuvant Therapy With Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Ultra Low Rectal Adenocarcinoma
Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the total neoadjuvant therapy mode for locally advanced ultra low rectal cancer to preserve the organs.
- Trial name
- RECMULRA-TNT (NCT05858567)
- Testing
- Envafolimab
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Sir Run Run Shaw Hospital
Gastroesophageal Junction (GEJ) Adenocarcinoma
An Open Label Phase 2 Study of Total Neoadjuvant Therapy (TNT) Consisting of FLOT With Pembrolizumab and Short Radiation for Patients With Locally Advanced Gastroesophageal Junction Adenocarcinoma
This study is to evaluate the effectiveness of treatment for esophagogastric junction carcinoma, total neoadjuvant therapy (TNT) including pembrolizumab and FLOT is conducted, aiming to choose between surgery or organ…
- Trial name
- NCT07018570
- Testing
- Pembrolizumab, Docetaxel, Oxaliplatin
- Where
- Japan
- Volunteers
- 26 people
- Sponsor
- National Cancer Center Hospital East
Locally Advanced Rectal Cancer (LARC)
A Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal Cancer
In a single-center, prospective, phase II study (ClinicalTrials registration number: [to be filled in]) initiated by our center to evaluate the safety and preliminary efficacy of short-course radiotherapy followed by sequential…
- Trial name
- NCT07347951
- Testing
- Short-course radiotherapy, CAPOX chemotherapy, Targeted therapy with bevacizumab
- Where
- China
- Volunteers
- 30 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University