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Patients will receive mFOLFOXIRI chemotherapy once every two weeks for at the most 12 cycles as adjuvant therapy

Patients will receive mFOLFOX6 chemotherapy once every two weeks for at the most 12 cycles as adjuvant therapy

mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 12 cycles at the most

mFOLFOXIRI

mFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 12 cycles at the most

mFOLFOX6

Yanhong Deng, Ph.D.

Jianwei Zhang, Ph.D.

Surgery is the main treatment method for colon cancer. About 50% of patients can be cured with surgery alone. For colon cancer with high-risk stage II or III after surgery, the current guidelines recommend 3-6 months after surgery. adjuvant chemotherapy to reduce the risk of recurrence and metastasis. However, for this part of the population, the overall benefit of adjuvant chemotherapy is limited, and different high-risk factors have different weights; some patients will still experience recurrence and metastasis even after receiving adjuvant chemotherapy. A number of previous studies have shown that patients with a positive ctDNA test on postoperative liquid biopsy without postoperative adjuvant therapy have a recurrence risk of 70-80%. Even if they receive adjuvant chemotherapy, the recurrence risk is significantly higher than that of ctDNA-negative patients. ctDNA has received increasing attention as a predictor of postoperative recurrence risk.

This study intends to randomly assign 1:1 to mFOLFOXIRI regimen adjuvant chemotherapy for 6 months and mFOLFOX6 regimen for colon cancer patients with postoperative high-risk stage II-III and liquid biopsy results within 1 month after surgery. Adjuvant chemotherapy was performed for 6 months, ctDNA was dynamically monitored after 3 months of treatment and at the end of adjuvant therapy. During the follow-up period, CEA was reviewed every 3 months, and chest, abdomen, and pelvis CT and ctDNA were reviewed every 6 months; the primary endpoint of the study was 2 years RFS, secondary endpoints included 3-year DFS, OS, safety and tolerability. Through intensive postoperative adjuvant therapy, we hope to screen colon cancer patients with high recurrence risk to receive adjuvant chemotherapy and improve the survival prognosis of ctDNA-positive colon cancer patients.

Adjuvant mFOLFOXIRI vs. mFOLFOX6 in MRD Positive Stage II-III Colorectal Cancer (AFFORD)

Adjuvant Modified FOLFOXIRI Versus mFOLFOX6 in Patients With Postoperative MRD Positive Stage II-III Colorectal Cancer: A Multicenter, Open Lable Randomized Phase 3 Study (AFFORD)

The DFS is defined as the time from the start of treatment to the date of first documented recurrence or metastais or death as a result of any cause, whichever occurred first.

OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

The DMFS is defined as the time from the start of treatment to the date of first documented distant metastais or death as a result of any cause, whichever occurred first.

Yanhong Deng

Professor

Patients will receive neoadjuvant treatment with mFOLFOXIRI plus cadonilimab for 6 cycles before surgey

Patients will receive neoadjuvant mFOLFOX6 chemotherapy every two weeks for 6 cycles before surgery.

Patients will receive neoadjuvant mFOLFOXIRI chemotherapy every two weeks for 6 cycles before surgery.

Cadonilimab（AK104）6mg/kg, intravenous d for 60 minutes, followed by mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) every 2 weeks for 6 cycles before surgery

mFOLFOXIRI + Cadonilimab

mFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) every 2 weeks for 6 cycels before surgery

mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) every 2 weeks for 6 cycles before surgery

Yanhong Deng, Ph.D

Jianwei Zhang, Ph.D

Yanghong Deng, PhD

Yanhong Deng, PhD

Neoadjuvant chemoradiotherapy (CRT) followed by total mesenteric excision (TME) and adjuvant chemotherapy was the standard of treatment for locally advanced rectal cancer (LARC) in the past two decades. The main obstacles for improving survival benefit of LARC was distant metastasis. Recently, total neoadjuvant therapy (TNT) had been recommended as new preferred option for LARC. Induction chemotherapy with FOLFOXIRI followed by CRT or short-course radiotherapy followed by FOLFOX chemotherapy had improved survival benefit for LARC.

Neoadjuvant immunotherapy had also been explored in pMMR patients with CRC. In the NICHE trial, neoadjuvant therapy with 2 dose of nivolumab and 1 dose of ipilimumab led to 29% of pathological response and 13% of pCR. Cadonilimab (AK104) was a PD-1/CTLA-4 bi-specific antibody. Here, we tried to explore the efficacy of Neoadjuvant Treatment With mFOLFOXIRI with or without Cadonilimab (AK104) Versus mFOLFOX6 in LARC.

This study was a prospective, randomized, uncontrolled phase II trial to evaluate the efficacy of mFOLFOXIRI combined with AK104 neoadjuvant therapy versus mFOLFOX6 neoadjuvant therapy in LARC.

The inclusion criteria: locally advanced colon cancer (T3\>5mm or T4 on enhanced CT assessment, with distant metastasis excluded); Locally advanced rectal cancer (pelvic MR assessment as stage ii-iii, less than 12cm from the anal margin, no distant metastasis), primary tumor location and TNM stage were stratified factors.

Group A: mFOLFOXIRI combined with Cadonilimab (AK104) for 6 cycles before surgery

Group B: 6 cycles of neoadjuvant chemotherapy with mFOLFOX6 before surgery

Group C: 6 cycles of neoadjuvant chemotherapy with mFOLFOXIRI before surgery

All groups were re-evaluated after 3 cycles and 6 cycles of treatment. If surgery was feasible after multidisciplinary evaluation, TME resection was performed, and adjuvant treatment was performed according to standard treatment after operation. For locally advanced rectal cancer, preoperative pelvic enhanced MRI was used to evaluate tumor regression after 6 cycles of preoperative treatment. For patients who still had MRF+ and/or T4 after treatment, additional short-course radiotherapy was allowed.

Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer

Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 Alone in Locally Advanced Colorectal Cancer: a Randomized Control Phase II Study (OPTICAL-2)

Proportion of patients experiencing a pCR to preoperative treatment in each group

The proportion of patients experiencing a major pathological response (≤10% of residual viable tumor in the surgical specimen) to preopeartive treatment in each group

Defined as the time from randomization to relapse, metastasis or death from any cause.

Defined as the time from randomization to local recurrence.

Sun Yat-sen University

Director of Medical Oncology, Clinical Professor

Capecitabine

Patients will receive mFOLFOXIRI once every two weeks for 12 cycles as adjuvant chemotherapy. They can change the regimen to mFOLFOX6 or CapeOx after accepting not less than two complete chemotherapy regimen, if can not tolerate the adverse reaction of mFOLFOXIRI. Total 24 weeks.

Patients will receive mFOLFOX6 once every two weeks for 12 cycles as adjuvant chemotherapy or CapeOx once every three weeks for 8 cycles as adjuvant chemotherapy. Total 24 weeks.

mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150-165 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400-2800mg/m2 as a 46-48 hour continuous infusion on day 1)

mFOLFOX6(oxaliplatin 85 mg/m2, folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-48 hour continuous infusion on day 1)

CapeOx(Oxaliplatin 130 mg/m2 intravenous infusion on day 1,Capecitabine 1000 mg/m2 twice daily PO for 14 days)

mFOLFOX6 OR CapeOx

Ye Lechi, M.D.

This study will focus on postoperative patients of stage IIIB or stage IIIC colorectal cancer. These patients will start to accept chemotherapy in 3-4 weeks after operation, these patients were randomly divided into two groups, one group will accept adjuvant chemotherapy of mFOLFOX6 or CapeOX; another group will use mFOLFOXIRI, they can change the regimen to mFOLFOX6 or CapeOx after accepting not less than two complete chemotherapy regimen, if can not tolerate the adverse reaction of mFOLFOXIRI. The efficacy and safety of adjuvant chemotherapy will be compared between the two groups. Disease-free survival, overall survival, incidence of adverse reaction of chemotherapy and postoperative quality of life will be recorded.

This trial is a two-arm, open labelled, prospective, randomized phase II studies. The postoperative stage of eligible patients was stage IIIB or stage IIIC. These high risk patients will be randomly assigned, in a 1:1 ratio, to receive either mFOLFOXIRI or mFOLFOX6/CapeOx for 6 months as adjuvant chemotherapy.

mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or IIIC Colorectal Cancer

mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or Stage IIIC Colorectal Cancer: A Randomized Controlled Clinical Research

Defined as the time from randomization to relapse or death, whichever occurred first

Defined as the time from randomization to death from any cause

First Affiliated Hospital of Wenzhou Medical University

Rectal Neoplasms

Patients receive standard chemoradiotherapy

irinotecan 165 mg/m² IV day 1+ oxaliplatin 85 mg/m² IV day 1 + leucovorin 400 mg/m² day 1, fluorouracil 1200mg/m²/day \*2 days (total 2400 mg/m² over 48 hours) continuous infusion starting on day 1 of each 2 weeks cycle

Chemoradiotherapy

Guosheng Wu, MD

Weiqin Jiang, MD

Extramural Vascular Invasion Positive(EMVI+) is a high risk of distant metastasis for locally advanced rectal cancer(LARC) after resection. The study is to evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC in contrast to the efficacy of standard Chemoradiotherapy (CRT).

It is an investigator-initiated, multicentered, randomized controlled clinical study to evaluate the efficacy and safety of mFOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC in contrast to standard chemoradiotherapy. Patients of LARC with EMVI+ evaluated by pelvic magnetic resonance imaging (MRI) are enrolled in this trial. All patients will be randomized divided into two groups.

Experimental group will receive 3 cycles of mFOLFOXIRI, followed to be performed MRI to assess clinical response. If the tumor response is good enough (partial response or complete response), the patient will receive another 3 cycles of mFOLFOXIRI then surgery. On the contrary, if the tumor shows poor response (stable disease or progressive disease) or with mesorectal fascia-positive or ycT4a/b after re-evaluation, radiotherapy will be performed combined with capecitabine before operation. Control group will receive standard capecitabine based chemoradiotherapy.

Patients with mesorectal fascia-positive or ycT4a/b after re-evaluation would receive radiation before surgery, whereas responders would have immediate total mesorectal excision (TME). All patients will receive 4 cycles of XELOX as adjuvant chemotherapy after TME.

A Trial of Neoadjuvant mFOLFOXIRI Versus CRT in the EMVI Positive LARC

A Multicenter Randomized Controlled Phase II Trial of Neoadjuvant mFOLFOXIRI Versus Routine Chemoradiotherapy in the EMVI Positive Locally Advanced Rectal Cancer (TRICHEMO)

the proportion of tumor downstaging to ypT0-2N0M0

The incidence of \>=3 grade adverse events

Zhejiang Cancer Hospital

First Affiliated Hospital of Zhejiang University

Chief physician

Active treatment with mFOLFOXIRI or mFOLFOX6 q2w up to six months followed by structured Follow-up for up to five years after randomization

Structured Follow-up for up to five years after randomization

Oxaliplatin: 85 mg/m², 2h IV infusion on d1 Leucovorin: 400 mg/m², 1-2 h IV infusion on d1 5-FU: (optional: 400 mg/m² bolus, 2-5 min IV infusion), 2400 mg/m², 46 h IV infusion on d1 Cycles are repeated on day 15. A total of up to 12 cycles are administered.

Oxaliplatin: 85 mg/m², 2h IV infusion on d1 Irinotecan: 150 mg/m², 90 min IV infusion on d1 Leucovorin: 400 mg/m², 1-2 h IV infusion on d1 5-FU: 2400 mg/m², 46 h IV infusion on d1 Cycles are repeated on day 15. A total of up to 12 cycles are administered.

Dominik Modest, Prof. Dr.

Daniel Müller, Dr.

Ludwig Fischer von Weikersthal, Dr.

Daniel Pink, Dr.

Alexander Kiani, Prof. Dr.

Börge Arndt, Dr.

Markus Schuler, Dr.

Annette Dieing, Dr.

Jörg-Christian Rath, Dr.

Anke Reinacher-Schick, Prof. Dr.

Yon-Dschun Ko, Prof. Dr.

Ralf Ulrich Trappe, Prof. Dr.

Hagen Rudolph, Dr.

Carl Schimanski, Prof. Dr.

Nicolas Graf, PD Dr.

Gerhard Behre, Prof. Dr.

Lutz Jacobasch, Dr.

Steffen Dörfel

Christoph Roderburg, Prof. Dr.

Michael Stahl, Prof. Dr.

Stefan Kasper-Virchow, Prof. Dr.

Thorsten Götze, PD Dr.

Claus Bolling, Dr.

Christine Koch, Dr.

Michael Quante, Prof. Dr.

Jochen Wilke, Dr.

Jens Atzpodien, Prof. Dr.

Georg Schließer, Dr.

Yong-Jun Peter Jo, Dr.

Mascha Binder, Prof. Dr.

Marianne Sinn, PD Dr.

Arndt Vogel, Prof. Dr.

Vera Heuer, Dr.

Matthias Glanemann, Prof. Dr.

Josef Menzel, Prof.

Udo Lindig, Dr.

Bernhard Sibbing, Dr.

Christian Bogner, Dr.

Florian Kaiser, Dr.

Lothar Müller, Dr.

Ulrich Hacker, Prof. Dr.

Andrea Heider, Dr.

Christian Constantin, Dr.

Stefan Angermeier, Dr.

Christoph Kahl, Prof. Dr.

Markus Möhler, Prof. Dr.

Christina Balser, Dr.

Jorge Riera, Dr.

Hans-Joachim Tischler, Dr.

Ullrich Graeven, Prof. Dr.

Voker Heinemann, Prof. Dr.

Sylvie Lorenzen, Prof. Dr.

Martin Fuchs, Dr.

Meinolf Karthaus, Prof. Dr.

Christian Lerchenmüller, Dr.

Klaus Wethmar, Dr. Dr.

Siegfried Haas, Dr.

Ulf Reinhart, Dr.

Gabriele Siegler, Dr.

Caroline Schock, Dr.

Thomas Südhoff, Prof. Dr.

Michael Sandherr, PD Dr.

Matthias Paland, Dr.

Tobias Dechow, Prof. Dr.

Anke Schlenska-Lange, Dr.

Hans Jürgen Schlitt, Prof. Dr.

Stefan Kubicka, Prof. Dr.

Sebastian Bröckling, Dr.

Gerhard Gerhard Puchtler, Dr.

Larissa Henze, Dr.

Thomas Geer, Dr.

Ralph Naumann, Prof. Dr.

Wolfram Bohle, Dr.

Claudio Denzlinger, Prof. Dr.

Heinz Kirchen, Dr.

Thomas J. Ettrich, Dr.

Birgitta Killing, Dr.

Thomas Gabrysiak, Dr.

Matthias Sandmann, Dr.

Björn Schöttker, Dr.

This is an open-label, randomized, controlled, multicenter, phase III study with two parallel arms. Patients with metastatic colorectal cancer after definite interventional therapy of all lesions are randomized in a 2:1 fashion (favoring active therapy) to investigate the efficacy, patient reported quality of life and safety of mFOLFOXIRI/mFOLFOX-6 as additive treatment (Arm A) versus active follow-up/surveillance (Arm B).

The trial will consist of both a clinical and translational part. During the study, re-assessments (radiologic assessment, blood and QoL) will be conducted for all trial subject of the trial every 3 months. Tumor biopsies will be collected at screening (baseline sample) and in case of relapse of disease if a new tumor sample is obtained.

The objective of the re-assessments is detection of relapse either radiologically or within the translational material (blood samples with ctDNA dynamics and tumor - if available from relapses). CT scans of thorax/abdomen and/or MRI scans will be performed every 3 months within the 2 years after randomization. After the first two relapse-free years, intervals should be stretched to 6 months in the third and following years after study start. Structured follow-up for up to 60 months after randomization should be maintained for both arms.

Patients in Arm A receive additive study drug intervention (mFOLFOXIRI or mFOLFOX-6) for up to six months (12 cycles) after randomization with additional clinical and safety assessments.

open-label, randomized, controlled, multicenter, phase III study with two parallel arms

Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)

Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer Prospective, Randomized, Open, Multicenter Phase III Trial to Investigate the Efficacy of Active Post-resection/Ablation Therapy in Patients With Metastatic Colorectal Cancer

time from randomization to death or evidence of disease relapse/progression (whatever occurs first)

time from randomization to the date of death of any cause

Local or distant control of lesions according to ablative technique (surgery vs. ablation vs. radiation)

Type, incidence, severity, and causal relationship to active chemotherapy of non-serious adverse events and serious adverse events (severity evaluated according to CTCAE version 5.0)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adjuvant mFOLFOXIRI vs. mFOLFOX6 in MRD Positive Stage II-III Colorectal Cancer (AFFORD)	NCT05427669	Colorectal Canc...	mFOLFOXIRI mFOLFOX6	18 Years - 70 Years	Sun Yat-sen University
Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer	NCT05571644	Colorectal Canc...	mFOLFOXIRI + Ca... mFOLFOX6 mFOLFOXIRI	18 Years - 70 Years	Sun Yat-sen University
mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or IIIC Colorectal Cancer	NCT05200299	Colorectal Canc...	mFOLFOXIRI mFOLFOX6 OR Cap...	18 Years - 75 Years	First Affiliated Hospital of Wenzhou Medical University
A Trial of Neoadjuvant mFOLFOXIRI Versus CRT in the EMVI Positive LARC	NCT04423965	Locally Advance...	mFOLFOXIRI Chemoradiothera...	18 Years - 70 Years	First Affiliated Hospital of Zhejiang University
Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)	NCT05008809	Colorectal Canc...	mFOLFOX6 mFOLFOXIRI	18 Years -	Charite University, Berlin, Germany
Short-course Radiotherapy or Long-course Chemoradiation Followed by mFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer	NCT06417476	Rectal Neoplasm...	Short-course ra... Irinotecan Oxaliplatin Calcium Formate Fluorouracil Long-course che... Capecitabine	18 Years - 70 Years	Sun Yat-sen University
Neoadjuvant mFOLFOXIRI Chemotherapy Alone for Extramural Vascular Invasion Positive Locally Advanced Rectal Cancer	NCT04170530	Locally Advance...	mFOLFOXIRI	18 Years - 75 Years	First Affiliated Hospital of Zhejiang University
Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer	NCT05571644	Colorectal Canc...	mFOLFOXIRI + Ca... mFOLFOX6 mFOLFOXIRI	18 Years - 70 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for mfolfoxiri

Every month we try and update this database with for mfolfoxiri cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mfolfoxiri

Every month we try and update this database with for mfolfoxiri cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mfolfoxiri cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.