Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Regorafenib, Toripalimab, Radiotherapy, Regorafenib.
- Who it may be relevant to
- Registry conditions: Microsatellite Stable Metastatic Colorectal Cancer. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Randomized, Controlled Phase II Trial of Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab as Third-line Treatment in Patients With Metastatic Colorectal Cancer
Overview
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).
Interventions
- Drug Regorafenib
Regorafenib 120 mg orally once daily on days 1-21 of each 28 days cycle. - Drug Toripalimab
240 mg intravenously every 3 weeks - Radiation Radiotherapy
hypofractionated radiotherapy (5 fractions of 4-12Gy) and low-dose radiotherapy (5 fractions of 0.5-2Gy). - Drug Regorafenib
Regorafenib 80mg orally once daily on days 1-21 of each 28 days cycle.
Primary outcome measures
- OS [Time frame: Up to 2 years]
Secondary outcome measures (5)
- PFS [Time frame: Up to 2 years]
- DCR [Time frame: Up to 1 year]
- ORR [Time frame: Up to 1 year]
- DoR [Time frame: Up to 1 year]
- Adverse events [Time frame: Up to 1 year]
Eligibility criteria
Inclusion criteria
- Age ≥18 years old
- An Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Life expectancy of at least 3 months
- Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum
- At least one evaluable metastatic lesion for radiotherapy according to RECIST 1.1
- Progressed on or after the standard first-and second-line therapies or stopped standard therapy because of unacceptable toxic effects
- Previous radiotherapy completed at least 4 weeks before randomization
- 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
- Sign the informed consent and have good compliance
Exclusion criteria
- History of previous treatment with regorafenib and ICIs such as anti-PD-1 or anti-PD-L1 mAbs
- Current severe cardiovascular diseases such as unstable angina, congestive heart failure, or serious cardiac arrhythmia requiring medication
- Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment
- Active autoimmune diseases and immunodeficiencies, known history of organ transplantation, or systematic use of immunosuppressive agents
- 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
- Positive human immunodeficiency virus (HIV) infection, active syphilis infection, or active pulmonary tuberculosis infection
- Severe infections requiring systemic antibiotics, antifungal or antiviral therapy
- Uncontrollable pleural effusion, pericardial effusion, or ascites
- 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.
- Known history of severe neurological or mental illness such as schizophrenia, dementia, or epilepsy
- Known history of allergy to any component involved in this study.
- Pregnancy or breast-feeding women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Publications
- Zhou S, Wang C, Shen L, Wang Y, Zhang H, Wu R, Wang Y, Chen Y, Xuan Y, Xia F, Zhang Z, Wan J. Regorafenib alone or in combination with high/low-dose radiotherapy plus toripalimab as third-line treatment in patients with metastatic colorectal cancer: protocol for a prospective, randomized, controlled phase II clinical trial (SLOT). Front Oncol. 2023 Oct 5;13:1274487. doi: 10.3389/fonc.2023.1274487. PMID 37869085
Identifiers
NCT: NCT05963490 · FDRT-2023-118-3237