Fudan University Shanghai Cancer Center
Shanghai, China
Location contact
Fan Xia, MD
SUB_INVESTIGATOR
Fangqi Liu, MD
SUB_INVESTIGATOR
Menglong Zhou, MD
CONTACT
Sanjun Cai, MD
PRINCIPAL_INVESTIGATOR
Zhen Zhang, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07403877
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) Regimen A: Dual immune checkpoint blockade with nivolumab plus ipilimumab. 2) Regimen B: Nivolumab plus radiotherapy. 3) Regimen C: Nivolumab monotherapy. The primary objectives are to determine whether: 1) Dual immune checkpoint blockade (Regimen A) is superior to nivolumab monotherapy (Regimen C); and 2) Immunotherapy plus radiotherapy (Regimen B) is superior to nivolumab monotherapy (Regimen C). Methods: Participants will be randomized in a 1:1:1 ratio to one of the three arms. For patients with resectable tumors, surgical resection will be performed. In patients with low rectal cancer and poor prospects for sphincter preservation, a watch-and-wait (WW) strategy is an option if a clinical complete response (CR) is achieved following neoadjuvant therapy.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
Shanghai, China
Fan Xia, MD
SUB_INVESTIGATOR
Fangqi Liu, MD
SUB_INVESTIGATOR
Menglong Zhou, MD
CONTACT
Sanjun Cai, MD
PRINCIPAL_INVESTIGATOR
Zhen Zhang, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nivolumab 240 mg every 2 weeks
Ipilimumab 1 mg/kg every 3 weeks
Irradiation targeted to the primary lesion (5 Gy per fraction, total 4 fractions, delivered every 3 weeks).
Surgical resection will be performed in resectable cases.
For patients with low rectal cancer who are unable to preserve the anal sphincter, a watch-and-wait (WW) strategy can be considered if a clinical complete response (CR) is achieved.
Time frame: 1 month after surgery or the completion of neoadjuvant therapy
Proportion of patients achieving either clinical CR (and undergoing WW) or pathological CR (confirmed by pathology) among all evaluable patients.
Time frame: 1 month after surgery
Proportion of patients who achieve R0 resection.
Time frame: 6 months after the enrollment of the last subject
Proportion of patients with complete response (CR) or partial response (PR) to preoperative multimodal therapy. ORR will be evaluated using RESIST1.1 by CT/MRI of the chest, abdomen, and pelvis.
Time frame: 36 months after the enrollment of the last subject
The EFS was defined as the time from randomization to the first determination of inoperable disease progression, postoperative local recurrence or distant metastasis, tumor regrowth, or death from any cause, whichever occurs first.
Time frame: 36 months after the enrollment of the last subject
OS is defined as the time interval from enrollment to death of any reason or censoring.
Time frame: From the time of enrollment, assessed up to 28 days after the last dose of study therapy
Number of participants with treatment-related adverse events (TrAEs) reported between the first dose and 28 days after the last dose of study therapy as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
Time frame: During or one month after surgery
Surgery related adverse events (SRAEs) refer to complications which happen during or one month after surgery. Severe complications after surgery will be documented and classified by Clavien-Dindo classification, such as abdominal or GI tract bleeding, anastomotic fistula, pancreatic fistula of grade B or above, and incision complications (infection, bleeding, rupture).
Time frame: During or one month after surgery
Death from any cause within 30 days of the date of surgery will be considered a surgical mortality death.
Contact information is provided by the study sponsor or research team.
Fudan University
Other
A Phase II Randomized Controlled Trial of Neoadjuvant Immunotherapy With or Without Radiotherapy in Locally Advanced Microsatellite Instability-High/Mismatch Repair-Deficient Colorectal Cancer
Acronym: TORCH-OPTIMA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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