Clinical trials: pMMR/MSS Locally Advanced Rectal Cancer
Rectal Cancer
Short-course Radiation (SCRT) Followed by 6 Cycles of Cadonilimab Plus MFOLFOX6 As Neoadjuvant Therapy for Patients with Locally Advanced Rectal Cancer (LARC): a Multicenter, Two-arm Parallel, Open-label, Randomised Phase III Trial (NeoCaCRT-III)
The goal of this clinical trial is to learn if neoadjuvant short-course radiation (SCRT) followed by 6 cycles of cadonilimab plus mFOLFOX6 works to treat patients with locally advanced rectal cancer (LARC).
- Trial name
- NeoCaCRT-III (NCT06832917)
- Testing
- AK104 plus, Chemo only
- Volunteers
- 238 people
- Sponsor
- Wan He
Locally Advanced Rectal Cancer (LARC)
PCSK9 Inhibitor and PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy for pMMR/MSS Locally Advanced Rectal Cancer
This is a single-center, open-label, single-arm clinical study aimed at conducting a preliminary evaluation of the efficacy and safety of combining PCSK9 inhibitors and PD-1 inhibitors (dual inhibitors) with neoadjuvant…
- Trial name
- NCT06933251
- Testing
- Neoadjuvant Chemoradiotherapy Combined with PD-1 inhibitor Immunotherapy and PCSK9 Inhibitor Therapy
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- Guangdong Provincial People's Hospital
pMMR, MSS
Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer
Colorectal cancer of Mismatch Repair-proficient (pMMR)/ Microsatellite Stability (MSS) accounts for approximately 85% of all colorectal cancer patients, which might be insensitive to immunotherapy.
- Conditions
- pMMR, MSS, MSI-L, Locally Advanced Rectal Carcinoma
- Trial name
- NCT05731726
- Testing
- Serplulimab, Capecitabine, Oxaliplatin
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Zhejiang University
Locally Advanced Rectal Cancer (LARC)
To Explore a Single-arm Phase II Study on Intestinal Microbiota Transplantation Combined With Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Rectal Cancer Under MSS/pMMR
To evaluate the pathological complete response rate (pCR) of intestinal flora transplantation combined with short-course radiotherapy +CAPOX+ sintilimab in neoadjuvant therapy for locally advanced rectal cancer (pMMR/MSS type)
- Trial name
- NCT07738042
- Testing
- Sintilimab, CAPOX (oxaliplatin/capecitabine), Short-course radiotherapy
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Rectal Cancer
Assessment of Efficacy and Safety of PD-1 Monoclonal Antibody Combined With IL-2 and CapeOX in Neoadjuvant Therapy for Locally Advanced Rectal Cancer Prior to Surgery: A Prospective, Multi-center, Randomized Controlled Study
The objective is to evaluate whether the neoadjuvant combination of tislelizumab (a PD-1 inhibitor) with interleukin-2 (IL-2) chemotherapy can significantly increase the Objective Response Rate (ORR) and the Pathological Complete…
- Trial name
- NCT06884670
- Testing
- Interleukin-2, Radiotherapy, Tislelizumab
- Where
- 4 sites in China
- Volunteers
- 130 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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
Locally Advanced Rectal Cancer
Fruquintinib Plus PD-1 Antibody in pMMR / MSS Locally Advanced Rectal Cancer (LARC) With High Immune Score
This is a prospective, one arm phase II study aimed to observe the efficacy and safety of tislelizumab combined with fruquintinib in treatment of patients with pMMR / MSS locally advanced rectal cancer with high immune score.
- Trial name
- NCT04989855
- Testing
- Fruquintinib plus Tislelizumab
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Sun Yat-sen University
Colorectal Carcinoma
PD-1 Antibody Following Preoperative Chemoradiotherapy for Locally Advanced pMMR/MSS Rectal Cancer
In this open-label phase II study, patients will be scheduled for neoadjuvant treatment with PD-1 antibody following preoperative Chemoradiotherapy with capecitabine for pMMR/MSS rectal cancer staged as locally advanced…
- Trial name
- NCT04833387
- Testing
- PD-1 antibody
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Sun Yat-sen University
Locally Advanced Rectal Cancer
Combination of AK104 and Neoadjuvant Chemoradiotherapy in pMMR/MSS Locally Advanced Rectal Cancer
This is an open-label, single-arm study to investigate the efficacy and safety of AK104 (an Anti-PD1 and Anti-CTLA4 Bispecific Antibody) and neoadjuvant chemoradiotherapy in patients with pMMR/MSS locally advanced rectal cancer.
- Trial name
- NCT05980689
- Testing
- AK104, Capecitabine, Neoadjuvant Radiotherapy
- Where
- China
- Volunteers
- 33 people
- Sponsor
- Sun Yat-sen University
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
Locally Advanced Rectal Cancer
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and PCSK9 Inhibitor for pMMR/MSS Locally Advanced Mid-low Rectal Cancer
This is a multicenter, prospective, randomized controlled study to evaluate the effectiveness and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor in the treatment of patients with pMMR/MSS…
- Trial name
- NCT06304987
- Testing
- Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitor, Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitor
- Where
- 2 sites in China
- Volunteers
- 50 people
- Sponsor
- Beijing Friendship Hospital
Rectal Malignant Neoplasms
Iparomlimab/Tuvonralimab Integrating With Total Neoadjuvant Therapy for pMMR/MSS Locally Advanced Rectal Cancer (IT-TNT)
In colorectal cancer (CRC), ICIs show strong therapeutic associations with microsatellite instability-high (MSI-H) status, while patients with proficient mismatch repair/microsatellite stable (pMMR/MSS) tumors exhibit poor…
- Trial name
- NCT07026422
- Testing
- Total neoadjuvant therapy integrating iparomlimab/tuvonralimab with chemoradiotherapy
- Where
- China
- Volunteers
- 54 people
- Sponsor
- Shandong Cancer Hospital and Institute
Rectal Adenocarcinoma
A Phase ll Study of Neoadjuvant Short-course Radiotherapy Followed by Ivonescimab and Chemotherapy in pMMR/MSS Locally Advanced Rectal Cancer
The purpose of this study is to evaluate the efficacy and safety of short-course radiotherapy followed by ivonescimab and chemotherapy in participants with pMMR/MSS locally advanced rectal cancer.
- Trial name
- NCT06919510
- Testing
- lvonescimab, CAPOX (oxaliplatin/capecitabine), radiotherapy
- Volunteers
- 90 people
- Sponsor
- Sun Yat-sen University
Rectal Cancer, MSS
XELOX Combined With Cadonilimab Versus XELOX as Neoadjuvant Treatment for Locally Advanced, pMMR Rectal Cancer
This is a two-arm, open label, randomized phase II clinical study. The aim is to evaluate the safety and efficacy of Cadonilimab (a PD-1/CTLA-4 bispecific antibody) combined with XELOX regimen in pMMR locally advanced rectal…
- Trial name
- NCT05815303
- Testing
- Cadonilimab, Oxaliplatin, Capecitabine
- Where
- China
- Volunteers
- 92 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Short-course Radiotherapy Plus Chemotherapy, Nodal-Region Sparing Short-Course Radiotherapy Followed by Sequential Chemotherapy With PD-1 Monoclonal Antibody and Bevacizumab
Nodal-Region Sparing Short-Course RT With Chemo-PD-1/Bevacizumab vs. Short-Course RT With Chemotherapy as TNT in pMMR/MSS Locally Advanced Rectal Cancer
Safety and efficacy of Nodal-Region Sparing Short-Course Radiotherapy Followed by Sequential Chemotherapy With PD-1 Monoclonal Antibody and Bevacizumab versus Short-course Radiotherapy plus Chemotherapy as Total Neoadjuvant…
- Trial name
- SPARK II (NCT07674732)
- Testing
- Short-course Radiotherapy plus Chemotherapy, Nodal-Region Sparing Short-Course Radiotherapy Followed by Sequential Chemotherapy With PD-1 Monoclonal Antibody and Bevacizumab
- Where
- China
- Volunteers
- 76 people
- Sponsor
- Dechang Diao
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
Colorectal Cancer (CRC)
Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer
This is a prospective, open-label, randomized, parallel-group phase II trial evaluating the efficacy and safety of a low-dose radiotherapy sensitization strategy combined with a PD-1 antibody (pucotenlimab) and CAPEOX as…
- Trial name
- NCT07448142
- Testing
- Low-dose radiotherapy, Pucotenlimab, CAPEOX/XELOX
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Sun Yat-sen University
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
Locally Advanced Rectal Cancer
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer
This is an open, prospective, multi-center, single-arm phase II clinical study assessing the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin in patients with pMMR/MSS locally…
- Trial name
- NCT06056804
- Testing
- capecitabine, tislelizumab, thymalfasin
- Where
- 2 sites in China
- Volunteers
- 20 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