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Trial Title:
Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer
NCT ID:
NCT05963490
Condition:
Microsatellite Stable Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Regorafenib
Description:
Regorafenib 120 mg orally once daily on days 1-21 of each 28 days cycle.
Arm group label:
monotherapy
Other name:
Stivarga
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
240 mg intravenously every 3 weeks
Arm group label:
combination therapies
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
hypofractionated radiotherapy (5 fractions of 4-12Gy) and low-dose radiotherapy (5
fractions of 0.5-2Gy).
Arm group label:
combination therapies
Intervention type:
Drug
Intervention name:
Regorafenib
Description:
Regorafenib 80mg orally once daily on days 1-21 of each 28 days cycle.
Arm group label:
combination therapies
Summary:
The study compares the efficacy and safety of regorafenib alone or in combination with
hypofractionated radiotherapy and low-dose radiotherapy (LDRT) plus toripalimab in
patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). Patients are
randomly assigned (1:1) into the control arm and the experimental arm. Control arm: a
total of 54 patients will receive regorafenib monotherapy. Experimental arm: a total of
54 patients will first receive 1 cycle of regorafenib and toripalimab followed by
hypofractionated/low-dose radiotherapy. Regorafenib and toripalimab will be continued
after the completion of radiotherapy. The survival benefits, response rates, and adverse
effects will be analyzed.
Detailed description:
Control arm: regorafenib 120 mg orally once daily on days 1-21 of each 28 days cycle.
Experimental arm: regorafenib is administered 80 mg once daily on days 1-21 of each 28
days cycle with intravenous toripalimab 240 mg every 3 weeks. Radiotherapy regimes
include hypofractionated radiotherapy (5 fractions of 4-12Gy) and low-dose radiotherapy
(5 fractions of 0.5-2Gy).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years old
2. An Eastern Cooperative Oncology Group (ECOG) performance status ≤1
3. Life expectancy of at least 3 months
4. Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum
5. At least one evaluable metastatic lesion for radiotherapy according to RECIST 1.1
6. Progressed on or after the standard first-and second-line therapies or stopped
standard therapy because of unacceptable toxic effects
7. Previous radiotherapy completed at least 4 weeks before randomization
8. Adequate bone-marrow, hepatic, and renal function: neutrophils ≥ 1.5 × 10^9/L, Hb ≥
90 g/L, PLT ≥ 100 × 10^9/L, ALT/ AST≤2.5 ULN, Cr≤1 ULN
9. Sign the informed consent and have good compliance
Exclusion Criteria:
1. History of previous treatment with regorafenib and ICIs such as anti-PD-1 or
anti-PD-L1 mAbs
2. Current severe cardiovascular diseases such as unstable angina, congestive heart
failure, or serious cardiac arrhythmia requiring medication
3. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before
recruitment
4. Active autoimmune diseases and immunodeficiencies, known history of organ
transplantation, or systematic use of immunosuppressive agents
5. Active Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection: HBsAg positive
or HBV DNA positive, anti-HCV antibody testing positive and confirmatory HCV RNA
positive
6. Positive human immunodeficiency virus (HIV) infection, active syphilis infection, or
active pulmonary tuberculosis infection
7. Severe infections requiring systemic antibiotics, antifungal or antiviral therapy
8. Uncontrollable pleural effusion, pericardial effusion, or ascites
9. Other malignancies within 5 years before recruitment, except for non-melanoma skin
cancer, superficial bladder cancer, cervical carcinoma in situ, or breast cancer in
situ that had been effectively treated.
10. Known history of severe neurological or mental illness such as schizophrenia,
dementia, or epilepsy
11. Known history of allergy to any component involved in this study.
12. Pregnancy or breast-feeding women
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhen Zhang, MD, PHD
Phone:
18801735029
Email:
zhen_zhang@fudan.edu.cn
Start date:
April 25, 2023
Completion date:
April 25, 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05963490
