Colorectal Cancer Liver MetastasesPhase 2NCT05485909

Phase II Study of Regorafenib and Toripalimab Combined With RFA in Patients With CRCLM

A Phase 2 study testing Radiofrequency ablation and Regorafenib and Toripalimab Combination in people with Colorectal Cancer Liver Metastases, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer Liver Metastases
What is being tested?: Radiofrequency ablation and Regorafenib and Toripalimab Combination
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteChina
Study dates: 25 Jul 2022to 30 Jun 2024
Phase: Phase 2
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

Males and females aged ≥18 years;
Histologically or cytologically confirmed colon or rectal adenocarcinoma, with unresectable relapsed or metastatic disease;
Microsatellite stability (MSS) or microsatellite instability-low (MSI-L), or proficient expression of DNA mismatch repair gene (pMMR);
Patients who have failed, or can not tolerate after previous systemic treatment for relapsed or metastatic colorectal cancer, with no more than 3 months for disease progression after the last systemic treatment. The systemic treatment must contain fluorouracil, oxaliplatin and irinotecan, with or without targeted therapy (bevacizumab, cetuximab, and so on);
According to the RECIST 1.1 standard, in addition to the lesion to be ablated and the measurable lesion outside the liver, there is at least one measurable lesion in the liver. Measurable lesions were defined as non-lymph node lesions with the longest single diameter ≥ 10 mm, or lymph node lesions with a short diameter ≥ 15 mm;
ECOG score 0-1;

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Expected survival ≥3 months;
Good organ function (without blood transfusion, use of hematopoietic stimulating factors, or transfusion of albumin or blood products within 14 days prior to examination):
1）Platelet (PLT) count ≥100,000 /mm3; 2) Neutrophil count (ANC) ≥1,500 /mm3; 3) Hemoglobin (Hb) level ≥9.0 g/dl; 4) International normalized ratio (INR) ≤1.5; 5) Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN; 6) Total bilirubin (TBIL) level ≤1.5×ULN; 7) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level ≤2.5×ULN (≤5×ULN in case of liver metastasis); 8) Alkaline phosphatase level ≤2.5×ULN (≤5×ULN in case of liver metastasis); 9) Serum creatinine (Cr) level ≤1.5×ULN and creatinine clearance ≥60 ml/min; 10) Thyroid stimulating hormone (TSH) ≤ULN; 11) Normal serum free thyroid hormone (T4); 12) Normal serum free triiodothyronine (T3); 13) Serum amylase ≤1.5×ULN; 15) Lipase ≤1.5×ULN.
9. Females of child bearing age must have a negative pregnancy test, and have to take contraception measures and avoid breast feeding during the study and for 3 months after the last dose; male subjects must agree to taken contraception measures during the study and for 3 months after the last dose.
10. Able to understand and willing to sign written informed consent form.

Who cannot join

Diagnosis of any other malignancy at different primary site or of different histological type from colorectal cancer within 5 years prior to initiation of study treatment, except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of cervix;
Microsatellite instability-high (MSI-H) or deficient expression of DNA mismatch repair gene (dMMR);
Previous treatment with regorafenib, PD-1/PD-L1/PD-L2 antibody or any other antibody that acts on T cell costimulatory or checkpoint pathways;
Known allergy to study drug or excipients, or allergy to similar drugs;
Have received other anti-tumor treatment within 4 weeks prior to initiation of study treatment, or no more than 5 half lives from the last dose;
Have participated in other clinical study and received drug within 4 weeks prior to initiation of study treatment;

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Have undergone major surgery or open biopsy, or have massive trauma within 4 weeks prior to initiation of study treatment;
Have received immunosuppressants (excluding inhaled corticosteroids or ≤10 mg/day prednisone or other systemic steroids at equivalent pharmaphysiological dose) within 2 weeks prior to initiation of study treatment;
Have vaccination with attenuated live vaccines within 4 weeks prior to initiation of the study treatment or plan to vaccinate during the study;
CYP3A4 inducers or inhibitors should not be stopped within 1 week prior to initiation of study treatment and during the study;
Known metastasis to central nervous system;
Present or history of any autoimmune disease;
Human immunodeficiency virus (HIV) infection (HIV antibody positive), or active hepatitis C virus (HCV) infection (HCV antibody positive), or active hepatitis B virus (HBV) infection (HBsAg or HBcAb positive, and HBV-DNA ≥2000 IU/ml (copies/ml)), or other severe infection requiring systemic antibiotic treatment, or unexplained body temperature >38.5℃ during screening period/before study treatment;
Presence of pleural effusion, peritoneal effusion, or pericardial effusion;
Development of the following diseases within 6 months prior to initiation of study treatment: myocardial infarction, severe/unstable angina, congestive heart failure above NYHA grade 2, poorly controlled arrhythmia;
Poorly controlled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
With bleeding tendency, or evident hemoptysis or other hemorrhagic events (e.g. gastrointestinal hemorrhage, hemorrhagic gastric ulcer) within 2 months prior to initiation of study treatment, or presence of hereditary or acquired bleeding or thrombotic tendency (e.g. hemophilia, coagulopathy, thrombocytopenia, etc.), or current/long-term thrombolytic or anticoagulant therapy (except aspirin ≤100 mg/day);
Development of arterial/venous thrombotic events, e.g. cerebrovascular accident (transient ischemic attack, cerebral hemorrhage, cerebral infarction etc.), deep venous thrombosis, vasculitis, etc. within 6 months prior to initiation of study treatment;
History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
Seizure requiring drug (e.g. steroids or antiepileptic drugs) treatment;
Presence of malabsorption disorder;
Unable to swallow study drug;
Presence of toxicities (except alopecia) of grade 2 and above (CTCAE V5.0) due to previous anti-tumor treatment or surgical procedure;
History of drug abuse, illegal drug use or alcohol dependence;
Patients with other severe acute or chronic conditions that may increase the risk of participation in the study and study treatment, or may interfere with interpretation of study results, and judged by the investigator as not suitable for participation in this clinical trial.

Trial locations and contacts

1 site in 1 country.

Zhiqiang Wang contact

+8613825122020

wangzhq@sysucc.org.cn

China1 site, 1 recruiting

Zhiqiang Wang
Guangzhou, Other (Non U.s.), 510000
Zhiqiang Wang, +8613825122020, wangzhq@sysucc.org.cn
Recruiting

Other trials in China

About this study

Official title: A Single-arm, Single-center Phase II Clinical Study of Regorafenib and Toripalimab Combined With Radiofrequency Ablation (RFA) in Patients With Colorectal Cancer Liver Metastases

The incidence of colorectal cancer liver metastasis is high and the prognosis is poor. Improving the treatment effect of colorectal cancer liver metastasis is the key to improving the prognosis of colorectal cancer patients. Rigofenib is one of the standard third-line treatments for advanced colorectal cancer, but has limited efficacy. Immune checkpoint inhibitors (PD-L1 monoclonal antibody, PD-1 monoclonal antibody) have achieved good results in the treatment of various malignant tumors. In a mouse transplant tumor model of colorectal cancer, regorafenib combined with PD-1 monoclonal antibody treatment significantly improved the antitumor activity, but the efficacy rate in clinical studies was not very high, especially for liver metastases. Radiofrequency ablation (RFA) is one of the common methods for the treatment of liver metastases. RFA may improve the immune microenvironment and the efficacy of immunotherapy,and the purpose of this trial is to explore the efficacy and safety of rigofenib and terepliumab combined with RFA in patients with refractory colorectal cancer liver metastasis.

Conditions: Colorectal Cancer Liver Metastases
Being tested: Radiofrequency ablation, Regorafenib and Toripalimab Combination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radiofrequency ablationOther
For multiple intrahepatic lesions, select 1 to 2 lesions for radiofrequency ablation
Regorafenib and Toripalimab CombinationDrug
Toripalimab 200 mg, iv drip, d1, d15, q4w, Regorafenib 80mg, po, d1-d21, Q4w.

Study groups in NCT05485909
Study group	Role	What they receive
Regorafenib and Toripalimab Combined with RFA	Experimental	Not described Receives: Other: Radiofrequency ablation; Drug: Regorafenib and Toripalimab Combination

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective response rate (ORR)
The ratio of patients who are evaluated as CR or PR
Measured: 2 years

Secondary outcomes (5)

Progression free survival (PFS)
Time from first dose to first documented disease progression or death from any cause (whichever occurs first)
Measured: 2 years
Overall survival (OS)
Overall survival (OS) was defined as the time (days) from randomization to death due to any cause.
Measured: 2 years
Disease control rate (DCR)
Defined as the proportion of patients whose tumors shrink or remain stable for a certain period of time, including CR, PR and SD
Measured: 2 years
Duration of response (DOR)
defined as the time between the first assessment of a tumor as PR or CR and the first assessment as PD or any cause of death
Measured: 2 years.
Time to disease progression (TTP)
Time from first dose to first documented disease progression
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jul 202230 Jun 2024

First posted3 Aug 2022
Study start25 Jul 2022 (estimated)
Primary completion30 Jul 2023 (estimated)
Study completion30 Jun 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Colorectal Cancer Liver MetastasesStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05485909
Sponsor's protocol ID: SL-B2022-319-003
Status last verified: Aug 2022
First submitted: 1 Aug 2022
Last updated: 3 Aug 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Zhiqiang Wang

+8613825122020

wangzhq@sysucc.org.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
RecruitingPhase 2
Circulating Tumor DNA Methylation-Guided Adjuvant Therapy Decision-Making in Patients With Resectable Colorectal Cancer Liver Metastases After Resection
Colorectal Cancer Liver Metastases (CRLM), ctDNA
RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer

All Colorectal Cancer Liver Metastases trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-arm, Single-center Phase II Clinical Study of Regorafenib and Toripalimab Combined With Radiofrequency Ablation (RFA) in Patients With Colorectal Cancer Liver Metastases
ClinicalTrials.gov ID: NCT05485909
Acronym / sponsor ID: SL-B2022-319-003
Conditions: Colorectal Cancer Liver Metastases
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 32 participants (estimated)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 25 Jul 2022 (estimated)
Primary completion: 30 Jul 2023 (estimated)
Study completion: 30 Jun 2024 (estimated)
First posted: 3 Aug 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Regorafenib and Toripalimab Combined with RFA	Experimental	Other: Radiofrequency ablation, Drug: Regorafenib and Toripalimab Combination

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Males and females aged ≥18 years;
Histologically or cytologically confirmed colon or rectal adenocarcinoma, with unresectable relapsed or metastatic disease;
Microsatellite stability (MSS) or microsatellite instability-low (MSI-L), or proficient expression of DNA mismatch repair gene (pMMR);
Patients who have failed, or can not tolerate after previous systemic treatment for relapsed or metastatic colorectal cancer, with no more than 3 months for disease progression after the last systemic treatment. The systemic treatment must contain fluorouracil, oxaliplatin and irinotecan, with or without targeted therapy (bevacizumab, cetuximab, and so on);
According to the RECIST 1.1 standard, in addition to the lesion to be ablated and the measurable lesion outside the liver, there is at least one measurable lesion in the liver. Measurable lesions were defined as non-lymph node lesions with the longest single diameter ≥ 10 mm, or lymph node lesions with a short diameter ≥ 15 mm;

Key exclusion criteria (25 listed)

Diagnosis of any other malignancy at different primary site or of different histological type from colorectal cancer within 5 years prior to initiation of study treatment, except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of cervix;
Microsatellite instability-high (MSI-H) or deficient expression of DNA mismatch repair gene (dMMR);
Previous treatment with regorafenib, PD-1/PD-L1/PD-L2 antibody or any other antibody that acts on T cell costimulatory or checkpoint pathways;
Known allergy to study drug or excipients, or allergy to similar drugs;
Have received other anti-tumor treatment within 4 weeks prior to initiation of study treatment, or no more than 5 half lives from the last dose;

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
Radiofrequency ablationFor multiple intrahepatic lesions, select 1 to 2 lesions for radiofrequency ablation	Other	Regorafenib and Toripalimab Combined with RFA
Regorafenib and Toripalimab CombinationToripalimab 200 mg, iv drip, d1, d15, q4w, Regorafenib 80mg, po, d1-d21, Q4w.	Drug	Regorafenib and Toripalimab Combined with RFA

Primary outcome

Objective response rate (ORR)
Time frame: 2 years
The ratio of patients who are evaluated as CR or PR

5 secondary outcomes

Progression free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years.
Time to disease progression (TTP)
Time frame: 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.

Related trials for Colorectal Cancer Liver Metastases

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
RecruitingPhase 2
Circulating Tumor DNA Methylation-Guided Adjuvant Therapy Decision-Making in Patients With Resectable Colorectal Cancer Liver Metastases After Resection
Colorectal Cancer Liver Metastases (CRLM), ctDNA
RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer

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.

Zhiqiang Wang contact

+8613825122020

wangzhq@sysucc.org.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiofrequency ablation and Regorafenib and Toripalimab Combination in people with Colorectal Cancer Liver Metastases, run by Sun Yat-sen University at 1 site in 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 11 inclusion and 25 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 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Zhiqiang Wang (+8613825122020, wangzhq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05485909.

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 3 Aug 2022.