Colorectal Cancer MetastaticPhase 1NCT06283303
A Clinical Study of T3011 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer
A Phase 1 study testing T3011 hepatic artery infusion, toripalimab and regorafenib in people with Colorectal Cancer Metastatic, run by China Medical University, China.
Trial summary
This is a phase I, open-label clinical study of T3011 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- T3011 hepatic artery infusion, toripalimab and regorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2024to 30 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged ≥18 years at the time of signing the Informed Consent Form (ICF);
- Patients with a definitive histopathological or cytological diagnosis of colorectal cancer with hepatic metastases who have received and failed at least second-line standard therapy in the past, or who have been assessed by the investigator to be unsuitable for standard therapy;
- Patients with at least one measurable lesion (as defined by RECIST v1.1) that has not been previously treated with radiotherapy (unless definite progression of the lesion has occurred after radiotherapy);
- Eastern Cooperative Oncology Group(ECOG) score 0 or 1;
- Expected survival ≥ 12 weeks;
- For female subjects with childbearing potential, a negative serum pregnancy test within 7 days prior to the first dose of study drug; Acceptance of using medically accepted and effective contraception for at least 6 months after signing the ICF and until the last dose of study drug;
- Male subjects with childbearing potential agree to use medically accepted and effective contraception from the date of signing the ICF to the date of at least 6 months after the last dose; in addition, the male subject must agree that he will not donate sperm during this period;
- Understand and voluntarily sign a written ICF and be willing to comply with all trial requirements.
Who cannot join
- Patients allergic to the study drug (including its components) or other similar products;
- Patients who have been treated with oncolytic virus therapy, interleukin-12 (IL-12) in combination with anti PD-1/ PD-L1;
- Patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia, fatigue or other tolerable events judged by the investigator);
- Patients with brain metastases that have progressed within 3 months prior to study drug administration (brain metastases that have stabilised within 3 months may be included);
- History of other malignancies (except cured basal cell skin cancer, cervical carcinoma in situ, papillary thyroid cancer, etc.) within 5 years prior to study drug administration;
- Patients who received any antineoplastic drug (including but not limited to chemotherapy, biologics, herbal preparations, etc.) within 4 weeks or 5 half-lives (whichever is shorter) prior to study drug administration;
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- Severe hepatic dysfunction (Child Pugh class C), or significant jaundice, hepatic encephalopathy, refractory pleural effusion, or hepatorenal syndrome; Coagulation: international normalized ratio (INR) or Prothrombin time (PT) > 1.5 x Upper limits of normal(ULN) ; activated partial thromboplastin time (aPTT)> 1.5 x ULN; Current comorbidity with active hepatitis: persistent or active hepatitis B (i.e. HBsAg positive or hepatitis B virus (HBV) DNA ≥ upper limit of detection), hepatitis C (HCV RNA ≥ upper limit of detection)] or other hepatitis; Haematology: white blood cell count (WBC) < 3.0 x 10^9/L; platelets < 75 x 10^9/L; haemoglobin < 80g/L; Renal function: serum creatinine >1.5 ULN or creatinine clearance <60 mL/min (Cockcroft-Gault formula calculation)
- Serious or uncontrollable cardiac disease requiring treatment, congestive heart failure classified as grade 3 or 4 by the New York Heart Association (NYHA), unstable angina not controlled by medication, history of myocardial infarction within 6 months prior to enrolment, serious arrhythmia requiring medication (except atrial fibrillation or paroxysmal supraventricular tachycardia); History of arterial thromboembolic event, venous thromboembolic event of grade ≥3 as defined in NCI CTCAE 5.0, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to randomisation; Current major vascular disease such as aortic aneurysm, aortic coarctation aneurysm, etc. that may be life-threatening or require surgery within 6 months;
- Previous immunotherapy (including but not limited to PD-1/PD-L1) with immune-related pneumonitis or ≥ grade 3 other immune-related adverse reactions; Current active immune disease requiring systemic treatment with immunosuppressive agents (excluding autoimmune diseases such as vitiligo that do not require intervention, or hypothyroidism that only needs hormone replacement therapy), or immune disease requiring systemic treatment with immunosuppressive agents (e.g., systemic lupus erythematosus) that is likely to recur; Patients with other diseases currently requiring systemic immunosuppressive therapy;
- HIV Positive; Patients who are currently in the midst of an episode of orofacial herpes; Clinically significant infection or infection treated with intravenous antibiotics within 4 weeks prior to dosing;
- Inability to swallow, malabsorption syndrome, or uncontrollable nausea, vomiting, diarrhoea or other gastrointestinal disorders that would seriously interfere with drug administration and absorption;
- Patients who need anti-herpes simplex virus medications (including, but not limited to, acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir, etc.) for the duration of the study, with the exception of topical applications;
- History of seizures within 12 months prior to study drug administration;
- Patients with the history of drug use or a history of substance abuse (including alcohol) within one year prior to signing the ICF;
- Pregnant or lactating women;
- Other reasons judged by the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Clinical Study to Evaluate the Safety and Efficacy of Herpes Virus T3011 Injection in Combination With Toripalimab and Regorafenib in Patients With Liver Metastases From Colorectal Cancer
This is a phase I, open-label clinical study of T3011 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer.
Read the detailed description
This trial is a prospective, open-label, investigator-initiated clinical study in patients with liver metastasis from colorectal cancer, aiming to evaluate the safety and efficacy of T3011 herpes virus injection alone or in combination with toripalimab and regorafenib in patients with liver metastasis from colorectal cancer. In this study, the lead-in period of T3011 and the combination therapy period were designed, and the 3+3 dose escalation design was carried out in the lead-in period.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- T3011 hepatic artery infusion, toripalimab, regorafenib
- Keywords
- oncolytic virus, colorectal Cancer, liver metastasis, hepatic artery infusion
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T3011 hepatic artery infusionBiological
The study was divided into two dose groups, T3011 3×10^8 PFU/time (HAI) and T3011 1×10^9 PFU/time (HAI), with a 3+3 dose escalation design. After the completion of the lead-in period, the patient entered the combination therapy period（combination therapy with T3011 hepatic artery infusion , Regorafenib and Toripalimab）,and the dosage of T3011 was determined according to the safety observation results of the lead-in period, the dose of toripalimab was 80mg intravenously, and regorafenib was 80mg orally once a day.
toripalimabDrug
The combination therapy period: toripalimab, 80mg intravenous ,D2 and D16, 4 weeks per cycle
regorafenibDrug
The combination therapy period: regorafenib ,80mg orally once a day, D1-D21,4 weeks per cycle
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy with T3011 hepatic artery infusion , Regorafenib and Toripalimab | Experimental | The study was divided into two dose groups, T3011 3×10^8 plaque forming unit(PFU)/time (HAI) and T3011 1×10^9 PFU/time (HAI), with a 3+3 dose escalation design. After the completion of the lead-in period, the patient entered the combination therapy period（combination therapy with T3011 hepatic artery infusion , Regorafenib and Toripalimab）,and the dosage of T3011 was determined according to the safety observation results of the lead-in period, the dose of toripalimab was 80mg intravenously, and regorafenib was 80mg orally once a day. Receives: Biological: T3011 hepatic artery infusion; Drug: toripalimab; Drug: regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Event（TEAE）
An adverse event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state.
Measured: Complete records until 30 days after the end-of-trial visit (i.e. end of treatment or early termination visit)
Secondary outcomes (3)
Objective response rate (ORR)
Objective response rate (ORR) as assessed by the investigators
Measured: Imaging was performed after completion of the introductory period, i.e. at week 4, and tumour assessment was performed every 8 weeks during the subsequent combined treatment period，assessed up to 100 months
Overall survival (OS)
The time from the start of treatment to death for any cause
Measured: Every 3 months until consent withdraw, death, withdrawal study, or loss of follow-up, assessed up to 100 months
Progression-free survival (PFS)
The time from the start of treatment to progress diease or death for any cause
Measured: Every 8 weeks until disease progression, consent withdraw, death or end of study, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start2 Apr 2024 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Immvira Co., Limited
- Responsible party
- Principal investigator, Funan Liu, China Medical University, China
- Investigators
- Zhenning Wang, MD, Principal investigator, The First Affiliated Hospital of China Medical UniveristyFunan Liu, MD, Principal investigator, The First Affiliated Hospital of China Medical Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283303
- Sponsor's protocol ID
- MVR-T3011-HAI-01
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Efficacy of Herpes Virus T3011 Injection in Combination With Toripalimab and Regorafenib in Patients With Liver Metastases From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06283303
- Acronym / sponsor ID
- MVR-T3011-HAI-01
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- oncolytic virus, colorectal Cancer, liver metastasis, hepatic artery infusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Collaborators
- Immvira Co., Limited
- Study start
- 2 Apr 2024 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I, open-label clinical study of T3011 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer.
Detailed description
This trial is a prospective, open-label, investigator-initiated clinical study in patients with liver metastasis from colorectal cancer, aiming to evaluate the safety and efficacy of T3011 herpes virus injection alone or in combination with toripalimab and regorafenib in patients with liver metastasis from colorectal cancer. In this study, the lead-in period of T3011 and the combination therapy period were designed, and the 3+3 dose escalation design was carried out in the lead-in period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination therapy with T3011 hepatic artery infusion , Regorafenib and Toripalimab | Experimental | Biological: T3011 hepatic artery infusion, Drug: toripalimab, Drug: regorafenibThe study was divided into two dose groups, T3011 3×10^8 plaque forming unit(PFU)/time (HAI) and T3011 1×10^9 PFU/time (HAI), with a 3+3 dose escalation design. After the completion of the lead-in period, the patient entered the combination therapy period（combination therapy with T3011 hepatic artery infusion , Regorafenib and Toripalimab）,and the dosage of T3011 was determined according to the safety observation results of the lead-in period, the dose of toripalimab was 80mg intravenously, and regorafenib was 80mg orally once a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women aged ≥18 years at the time of signing the Informed Consent Form (ICF);
- Patients with a definitive histopathological or cytological diagnosis of colorectal cancer with hepatic metastases who have received and failed at least second-line standard therapy in the past, or who have been assessed by the investigator to be unsuitable for standard therapy;
- Patients with at least one measurable lesion (as defined by RECIST v1.1) that has not been previously treated with radiotherapy (unless definite progression of the lesion has occurred after radiotherapy);
- Eastern Cooperative Oncology Group(ECOG) score 0 or 1;
- Expected survival ≥ 12 weeks;
Key exclusion criteria (16 listed)
- Patients allergic to the study drug (including its components) or other similar products;
- Patients who have been treated with oncolytic virus therapy, interleukin-12 (IL-12) in combination with anti PD-1/ PD-L1;
- Patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia, fatigue or other tolerable events judged by the investigator);
- Patients with brain metastases that have progressed within 3 months prior to study drug administration (brain metastases that have stabilised within 3 months may be included);
- History of other malignancies (except cured basal cell skin cancer, cervical carcinoma in situ, papillary thyroid cancer, etc.) within 5 years prior to study drug administration;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T3011 hepatic artery infusionThe study was divided into two dose groups, T3011 3×10^8 PFU/time (HAI) and T3011 1×10^9 PFU/time (HAI), with a 3+3 dose escalation design. After the completion of the lead-in period, the patient entered the combination therapy period（combination therapy with T3011 hepatic artery infusion , Regorafenib and Toripalimab）,and the dosage of T3011 was determined according to the safety observation results of the lead-in period, the dose of toripalimab was 80mg intravenously, and regorafenib was 80mg orally once a day. | Biological | Combination therapy with T3011 hepatic artery infusion , Regorafenib and Toripalimab |
| toripalimabThe combination therapy period: toripalimab, 80mg intravenous ,D2 and D16, 4 weeks per cycle | Drug | Combination therapy with T3011 hepatic artery infusion , Regorafenib and Toripalimab |
| regorafenibThe combination therapy period: regorafenib ,80mg orally once a day, D1-D21,4 weeks per cycle | Drug | Combination therapy with T3011 hepatic artery infusion , Regorafenib and Toripalimab |
Primary outcome
Treatment Emergent Adverse Event（TEAE）
Time frame: Complete records until 30 days after the end-of-trial visit (i.e. end of treatment or early termination visit)
An adverse event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state.
3 secondary outcomes
Objective response rate (ORR)
Time frame: Imaging was performed after completion of the introductory period, i.e. at week 4, and tumour assessment was performed every 8 weeks during the subsequent combined treatment period，assessed up to 100 months
Overall survival (OS)
Time frame: Every 3 months until consent withdraw, death, withdrawal study, or loss of follow-up, assessed up to 100 months
Progression-free survival (PFS)
Time frame: Every 8 weeks until disease progression, consent withdraw, death or end of study, assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenning Wang, MD principal investigator
The First Affiliated Hospital of China Medical Univeristy
Funan Liu, MD principal investigator
The First Affiliated Hospital of China Medical Univeristy
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing T3011 hepatic artery infusion, toripalimab and regorafenib in people with Colorectal Cancer Metastatic, run by China Medical University, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuhui Song, bachelor (15004240769 ext. 024, 593900927@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Event（TEAE） (time frame: Complete records until 30 days after the end-of-trial visit (i.e. end of treatment or early termination visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.