Clinical trials: pMMR/MSS Locally Advanced Rectal Cancer
Rectal Cancer
Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMR/MSS Locally Advanced Rectal Cancer
The goal of this clinical trial is to learn if neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX works to treat mid-high pMMR/MSS locally advanced rectal cancer patients compared with CapeOX.
- Trial name
- PKUCH-R09 (NCT06443671)
- Testing
- CapeOX, Fruquintinib and Tislelizumab combined with mCapeOX
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Peking University Cancer Hospital & Institute
Colorectal Cancer
Comparing Efficacy and Safety of Enlituo® Versus Erbitux® Plus FOLFOX in Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Status.
This is a randomized, double-blind, phase III clinical trial. The study aims to demonstrate that the treatment regimen of Enlituo® plus FOLFOX is equivalent to that of Erbitux® plus FOLFOX in participants with RAS/BRAF wild-type…
- Trial name
- NCT07595276
- Testing
- Enlituo®, Erbitux®
- Where
- China
- Volunteers
- 608 people
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
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, pMMR (Microsatellite Stable Rectal Cancer)
Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer
This is a multicenter, phase III, randomized controlled trial. Eligible patients with pMMR/MSS locally advanced rectal cancer will be randomized in a 1:1 ratio to either the experimental group or the control group using…
- Trial name
- NCT07528209
- Testing
- Pucotenlimab combine with CAPOX, CAPOX
- Where
- China
- Volunteers
- 556 people
- Sponsor
- Sun Yat-sen University
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
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
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
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
Local Advanced Rectal Cancer, Radiotherapy
Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in pMMR/MSS Locally Advanced Rectal Cancer
This multicenter, randomized, controlled, phase III trial evaluates whether adding iparomlimab and tuvonralimab injection to CAPOX consolidation chemotherapy after short-course radiotherapy improves tumor response in patients…
- Conditions
- Local Advanced Rectal Cancer, Radiotherapy, Immunotherapy
- Trial name
- SCRIT (NCT07686640)
- Testing
- Short-Course Radiotherapy, Consolidation treatment (With ICIs), Consolidation treatment (Without ICIs)
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Shandong Cancer Hospital and Institute
Rectal Cancer
Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)
This multicenter, randomized controlled clinical trial (FIRM02 Study) aims to evaluate the effectiveness and safety of neoadjuvant mFOLFOX6 chemotherapy combined with PD-1 inhibitor (Serplulimab) in patients with MSS/pMMR locally…
- Trial name
- NCT07381400
- Testing
- mFOLFOX6, Serplulimab
- Volunteers
- 128 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Rectal Cancer, Moderately Hypofractionated Radiotherapy
Neoadjuvant Moderately Hypofractionated Radiotherapy Combined With Chemotherapy and Immunotherapy for High-risk pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Multi-center Randomized Control Phase II Trial
This study aims to observe and evaluate the efficacy and safety of moderately hypofractionated radiotherapy combined with chemotherapy and immunotherapy, compared with conventional neoadjuvant chemoradiotherapy, in patients with…
- Conditions
- Rectal Cancer, Moderately Hypofractionated Radiotherapy, Serplulimab, pMMR/MSS
- Trial name
- NCT07527520
- Testing
- Moderately Hypofractionated Radiotherapy, Serplulimab, CapOx+Long-course radiotherapy
- Where
- China
- Volunteers
- 165 people
- Sponsor
- Fudan University
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
Advanced Rectal Cancer
Short-course RT Followed by NALIRIFOX Plus Pucotenlimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS/pMMR
The goal of this clinical trial is conducted to evaluate the neoadjuvant regimen of short-course radiotherapy (SCRT) followed by NALIRIFOX chemotherapy plus Pucotenlimab immunotherapy for high-risk locally advanced rectal cancer.
- Trial name
- NCT07651007
- Testing
- iTNT-HX02
- Volunteers
- 29 people
- Sponsor
- Wang Xin
Rectal Adenocarcinoma, High-risk Locally Advanced
A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR/MSS Lower Rectal Adenocarcinoma (STAR Trial)
This study adopts a prospective randomized controlled design to evaluate the efficacy and safety of short-course radiotherapy followed by sequential PD-1 inhibitor and FOLFOX chemotherapy versus conventional regimens in high-risk…
- Conditions
- Rectal Adenocarcinoma, High-risk Locally Advanced, Short-course Radiotherapy (SCRT), Immunotherapy
- Trial name
- STAR (NCT07669220)
- Testing
- Short-course Radiotherapy, SCRT, Toripalimab
- Where
- China
- Volunteers
- 76 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Rectal Cancer, Radiotherapy
Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR/MSS Stage II-III Rectal Cancer
This study aims to evaluate the efficacy (pathological complete response rate) of short-course radiotherapy with preservation of tumor-draining lymph nodes followed by sequential PD-1 inhibitor neoadjuvant therapy in patients…
- Conditions
- Rectal Cancer, Radiotherapy, PD-1 Inhibitor
- Trial name
- PKUCH- R11 (NCT07394192)
- Testing
- short-course radiotherapy that preserves tumor-draining lymph nodes
- Volunteers
- 44 people
- Sponsor
- Peking University Cancer Hospital & Institute
Locally Advanced Rectal Cancer (LARC)
A Pospective, Single-arm, Multicenter Clinical Trial Evaluating Preoperative Neoadjuvant mFOLFOX6 Chemotherapy in Combination With PD1 Monoclonal Antibody in MSS/pMMR Locally Advanced Rectal Cancer
Preoperative neoadjuvant chemoradiotherapy can induce tumor regression and reduce the risk of postoperative recurrence, serving as the standard treatment for locally advanced rectal cancer.
- Trial name
- FIRM (NCT06688786)
- Testing
- neoadjuvant mFOLFOX6 chemotherapy combined with PD-1 inhibitor therapy
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Colorectal Cancer (CRC), pMMR/MSS Adenocarcinoma of the Colon or Rectum
mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody Vs. mFOLFOX6 in Locally Advanced pMMR/MSS CRC
Neoadjuvant immunotherapy has shown promising therapeutic effects in mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-H) colorectal cancer (CRC).
- Trial name
- BASKETⅢ (NCT06791512)
- Testing
- mFOLFOX6 + Bevacizumab + PD-1 monoclonal antibody, mFOLFOX6
- Where
- China
- Volunteers
- 166 people
- Sponsor
- Jun Huang
Rectal Cancer, Adenocarcinoma, Neoadjuvant Therapy
Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer
This prospective, single-center, randomized controlled trial aims to assessing the efficacy and safety of neoadjuvant chemoradiation plus Tislelizumab (PD-1 inhibitor) with or without Probio-M9 and subsequent TME surgery, by…
- Conditions
- Rectal Cancer, Adenocarcinoma, Neoadjuvant Therapy, Immunotherapy, Probio-M9
- Trial name
- NCRIT-PM9 (NCT07458529)
- Testing
- CRT+PD-1 inhibitor+Probio-M9
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Seventh Medical Center of PLA General Hospital
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
Colorectal Cancer (Locally Advanced or Metastatic), Colorectal Cancer Microsatellite Stable (MSS)
FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer
To evaluate the efficacy and safety of immune checkpoint inhibitor-based combination therapy with targeted therapy and chemotherapy in patients with locally advanced unresectable or metastatic colorectal cancer.
- Trial name
- NCT07446465
- Testing
- Serplulimab, Fruquintinib, mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Ye Xu