Clinical trials: LOCALLY ADVANCED RECTAL CANCER
pMMR/MSS Locally Advanced Rectal Cancer
Short-course Radiotherapy Followed by Sequential Chemotherapy With or Without PD-1 Monoclonal Antibody and Bevacizumab as Total Neoadjuvant Therapy in pMMR/MSS Locally Advanced Rectal Cancer （SPARK）
Safety and efficacy of Short-Course Radiotherapy Followed by Sequential Chemotherapy with or without PD-1 Monoclonal Antibody and Bevacizumab as Total Neoadjuvant Therapy in pMMR/MSS Locally Advanced Rectal Cancer.
- Trial name
- NCT07005570
- Testing
- Short-course radiotherapy followed by sequential chemotherapy combined with PD-1 monoclonal antibody and bevacizumab, Short-course radiotherapy followed by sequential chemotherapy
- Where
- China
- Volunteers
- 86 people
- Sponsor
- Dechang Diao
Colorectal Cancer Metastatic, Colorectal Cancer Recurrent
A Dose-Expansion Trial of Intravenous HNF4α srRNA for Unresectable or Metastatic Colorectal Cancer
This study is a single-arm, open-label, exploratory clinical trial. Building on the previous dose-escalation trial, this dose-expansion trial aims to evaluate the safety and tolerability of intravenous monotherapy with CD-GA-102…
- Conditions
- Colorectal Cancer Metastatic, Colorectal Cancer Recurrent, Colorectal Cancer Stage IV
- Trial name
- NCT07050394
- Testing
- CD-GA-102
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Changzheng Hospital
Locally Advanced Rectal Cancer
Translational Validation Study to Examine KFO179-1 Biomarker Scores for the Prediction and Prognosis of Advanced Primary Resectable Rectal Cancer Stages UICC-II-IV, With a 5-Fluorouracil-based Standard Radiochemotherapy Followed by Total Mesorectal Excision.
The objective of the TransValid-KFO179/GRCSG-Trial-A is the validation of potential biomarkers. These are predictive (Prediction of probability of response to a certain therapy) / prognostic (predicting long-term outcome)…
- Trial name
- TransValid-A (NCT03034473)
- Testing
- Translational Research and multimodal treatment
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- University Medical Center Goettingen
Colorectal Cancer
Neoadjuvant Prolgolimab Monotherapy in Locally Advanced MMR-deficient Colorectal Cancer
In this phase II study patients with stage II-III MSI/dMMR colorectal adenocarcinoma with no signs of distant metastases will be treated with immunotherapy (prolgolimab). The duration of treatment is 6 months (12 cycles)
- Trial name
- NCT06428487
- Testing
- Prolgolimab
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- Blokhin's Russian Cancer Research Center
Colorectal Cancer (CRC)
MRD-Guided Surveillance in Locally Advanced Mid-Low Rectal Cancer (SURVEILLANCE-III)
This study aims to explore the relationship between minimal residual disease (MRD) status and disease recurrence in patients with locally advanced mid-low rectal cancer.
- Trial name
- SURIII (NCT06879899)
- Volunteers
- 139 people
- Sponsor
- Fudan University
Rectal Cancer, Neoadjuvant Therapies
Modified Long-Course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for MSS/pMMR High-risk Mid/Low LARC (MODIFI-RC-I)
The goal of this clinical trial is to evaluate whether a total neoadjuvant therapy (TNT) regimen combining long-course chemoradiotherapy, sequential chemotherapy, and PD-1 inhibitor can improve response rates, enhance…
- Conditions
- Rectal Cancer, Neoadjuvant Therapies, Immune Checkpoint Therapy, Radiotherapy
- Trial name
- NCT06923345
- Testing
- Reduced CTV, Conventional CTV
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Cancer, Advanced Cancer
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population.
- Conditions
- Cancer, Advanced Cancer, Locally Advanced Carcinoma, Metastatic Solid Tumor
- Trial name
- NCT06440005
- Testing
- AGX101
- Where
- 7 sites in United States
- Volunteers
- 80 people
- Sponsor
- Angiex, Inc.
Colorectal Cancer (MSI-H)
Neoadjuvant Immunotherapy ± Radiotherapy in MSI-H/dMMR Locally Advanced Colorectal Cancer
This phase II clinical trial evaluates the efficacy and safety of three neoadjuvant regimens in patients with locally advanced microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) colorectal cancer (CRC): 1)…
- Trial name
- TORCH-OPTIMA (NCT07403877)
- Testing
- Nivolumab, Ipilimumab (1mg/kg), PULSAR
- Where
- China
- Volunteers
- 114 people
- Sponsor
- Fudan University
Rectal Cancer, Adenocarcinoma, Neoadjuvant Chemoradiation
Multicenter, Prospective, RCT：Investigation of Combined Modality Therapy for Locally Advanced Mid/Low Rectal Cancer.
At present, the combined modality treatment of preoperative neoadjuvant chemoradiotherapy (NCRT) followed by radical surgery has become the standard of care for the locally advanced mid/low rectal cancer, having been proved to…
- Trial name
- NCT03042000
- Testing
- non-NCRT, NCRT, capecitabine with oxaliplatin
- Volunteers
- 1,200 people
- Sponsor
- Peking Union Medical College Hospital
Colorectal Neoplasm, Colorectal Cancer
NEOadjuvant Chemotherapy Only Compared With Standard Treatment for Locally Advanced Rectal Cancer
The main clinical hypothesis is that compared to radio-chemotherapy for low and mid rectal tumors or surgery for high rectal tumors neoadjuvant chemotherapy reduces the rate of distant relapse without increasing the rate of local…
- Conditions
- Colorectal Neoplasm, Colorectal Cancer, Rectal Neoplasms, Chemotherapy Effect
- Trial name
- NEOLAR (NCT03280407)
- Testing
- Capecitabine, FOLFOX regimen (oxaliplatin/leucovorin/5FU), CAPOX (oxaliplatin/capecitabine)
- Where
- Denmark
- Volunteers
- 124 people
- Sponsor
- Zealand University Hospital
Rectal Cancer
Folfoxiri Plus Bevacizumab Followed by Chemoradiotherapy Plus Bevacizumab in Patients With Resectable Rectal Cancer
This study includes patients affected by advanced and resectable rectal adenocarcinoma. It provides an induction chemotherapy with FOLFOXIRI regimen plus Bevacizumab followed by Chemoradiotherapy plus Bevacizumab.
- Trial name
- TRUST (NCT03085992)
- Testing
- FOLFOXIRI plus Bevacizumab, Chemoradiotherapy plus Bevacizumab
- Where
- 4 sites in Italy
- Volunteers
- 49 people
- Sponsor
- Azienda Ospedaliero, Universitaria Pisana
Advanced Cancer, Advanced Solid Tumor
A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.
- Conditions
- Advanced Cancer, Advanced Solid Tumor, Melanoma, Metastasis
- Trial name
- NCT06362369
- Testing
- Alintegimod, Ipilimumab, Nivolumab
- Where
- 5 sites in United States
- Volunteers
- 126 people
- Sponsor
- 7 Hills Pharma, LLC
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
Rectal Cancer Patients
Total Neoadjuvant Therapy With PD-1 for Locally Advcancer Rectal Cancer
Research Objective:To investigate the efficacy and safety of the "total neoadjuvant chemoradiotherapy combined with immunotherapy" regimen for the treatment of locally advanced rectal cancer with high-risk features for…
- Trial name
- TNT-Immunity (NCT07214142)
- Testing
- PD-1
- Volunteers
- 30 people
- Sponsor
- The First Affiliated Hospital of University of Science and Technology of China
Envafolimab Combined With Chemoradiotherapy in the Treatment of Locally Advanced pMMR/MSS Rectal Cancer
Single-arm, Single-center, Exploratory Phase II Clinical Study of Envafolimab Combined With Chemoradiotherapy in the Treatment of Locally Advanced pMMR/MSS Rectal Cancer
Preoperative radiotherapy combined with 5-fluorouracil/capecitabine is currently the standard treatment for locally advanced rectal cancer.
- Trial name
- ESTIMATE (NCT06239870)
- Testing
- Envafolimab combined with chemoradiotherapy in the whole course of neoadjuvant therapy
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Yunnan Cancer Hospital
Rectal Cancer, Locally Advanced
Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer
A Single-arm phase II trial evaluating induction chemotherapy with FOLFIRINOXm followed by short course radiotherapy (RT) in locally advanced rectal carcinoma
- Trial name
- NCT05868317
- Testing
- Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan), Radiotherapy
- Where
- Tunisia
- Volunteers
- 70 people
- Sponsor
- Salah Azaïz Cancer Institute
Locally Advanced Rectal Carcinoma
Preoperative, Adaptive Radiotherapy Concomitant to Chemotherapy for Rectal Adenocarcinoma (Adaptive Rectal Cancer Trial 02)
The aim of this clinical study is to increase the rate of pathological responses up to 70% by means of improved patient selection operated by a radiobiological index called ERI_TCP and by an increase in the dose of radiotherapy…
- Trial name
- NCT07580027
- Testing
- Preoperative, adaptive radiotherapy
- Where
- Italy
- Volunteers
- 33 people
- Sponsor
- IRCCS San Raffaele
Locally Advanced Rectal Cancer
Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer
This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced rectal cancer
- Trial name
- NCT03443661
- Testing
- FOLFOXIRI
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Aiping Zhou
Local Advanced Rectal Cancer, PD-1 Inhibitor
Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR/ MSS Locally Advanced Rectal Cancer : A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Trial
This is a randomized, controlled clinical trial based on prior exploratory findings, designed to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tafolecimab(an anti-PCSK9 inhibitor) and sintilimab…
- Conditions
- Local Advanced Rectal Cancer, PD-1 Inhibitor, PCSK9 Inhibitor, RCT
- Trial name
- NCT07686796
- Testing
- Short-course radiotherapy, CAPOX (oxaliplatin/capecitabine), Sintilimab
- Where
- China
- Volunteers
- 148 people
- Sponsor
- Guangdong Provincial People's Hospital
Metastatic Colorectal Cancer (CRC)
A Study to Test Different Doses of BI 1701963 in Combination With Irinotecan in People With Advanced Bowel Cancer With Kirsten Rat Sarcoma Viral Oncogene Homologue (KRAS) Mutation
This study is open to adults with advanced bowel cancer (colorectal cancer) with a KRAS mutation. This is a study in people for whom previous treatment was not successful and surgery is not a treatment option.
- Trial name
- NCT04627142
- Testing
- BI 1701963, Camptosar®
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Boehringer Ingelheim