Colorectal CancerPhase 2NCT05894837
Serplulimab+Regorafenib +Hepatic Artery Bicarbonate Infusion in Patients With Colorectal Cancer and Liver Metastases
A Phase 2 study testing Serplulimab+Regorafenib and Hepatic Artery Bicarbonate Infusion in people with Colorectal Cancer and Liver Metastases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
A single-center, single-arm, phase 2 trial of Serplulimab in combination with Regorafenib and hepatic artery bicarbonate infusion for third-line treatment in patients with colorectal cancer and liver metastases. A total of 30 patients are planned to be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Liver Metastases
- What is being tested?
- Serplulimab+Regorafenib and Hepatic Artery Bicarbonate Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Jun 2025
- 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
- Age 18 or above, male or female;
- Patients with colorectal cancer and liver metastases who strictly conform to the clinical diagnostic criteria of "Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer (2020 Edition)" or who have been confirmed by histopathology or cytology;
- At least 1 measurable intrahepatic lesion;
- Child-Pugh liver function rating: A or good B (≤7 points) ;
- No local treatment including radiotherapy, surgical excision and ablation was performed before interventional therapy;
- No other malignant tumors;
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- ECOG score within one week before enrollment: 0-1;
- Predicted survival ≥24 weeks;
- The major organs are functioning normally; the following criteria are met: Blood examination: a) HB≥90 g/L；b) ANC≥1.5×109/L；c) PLT≥80×109/L; Biochemical examination: a) ALB ≥29 g/L；b) ALT and AST<5ULN；c) TBIL ≤1.5ULN；d) Creatinine≤1.5ULN；(Only one of the two measures of albumin and bilirubin in the Child-Pugh rating can be a score of 2); Thyroid function tests are within normal range；
- Women of childbearing age must already be using reliable contraception or have had a pregnancy test (serum or urine) with negative results within 7 days prior to inclusion and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last test drug administration；
- The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up；
Who cannot join
- There is a contraindication of anti-PD-1 monoclonal antibody therapy;
- With other uncured malignancies, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ;
- Patients who are preparing for an organ transplant or have had an organ transplant in the past；
- Ascites with clinical symptoms that require therapeutic abdominal puncture or drainage, or Child-Pugh score > 2；
- Patients with high blood pressure (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg) who cannot be reduced to the normal range by antihypertensive medication；
- Patients with grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450 ms for males and 470 ms for females); A history of symptomatic ischemic or hemorrhagic cerebrovascular disease；
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- Having multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction, which significantly affects drug administration and absorption)；
- Patients with a history of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within the past 6 months, such as esophageal varicose veins with bleeding risk, locally active ulcer lesions, stool occult blood ≥ (++), should not be included in the group; If fecal occult blood (+), gastroscopy is required；
- Had an abdominal fistula, gastrointestinal perforation, or abdominal abscess in the 28 days prior to joining the study；
- Patients with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds) who are prone to bleeding or are receiving thrombolytic or anticoagulant therapy；
- Patients with central nervous system metastases or known brain metastases；
- Patients with past and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function；
- Urine routine showed urine protein ≥++ or confirmed 24 hours urine protein quantity > 1.0 g；
- Severe thyroid disease cannot be controlled by treatment；
- Rheumatic or autoimmune diseases, and immunosuppressant or high-dose hormone therapy after organ transplantation；
Trial locations and contacts
1 site in 1 country.
China1 site
the Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Serplulimab in Combination With Regorafenib and Hepatic Artery Bicarbonate Infusion for Third-line Treatment in Patients With Colorectal Cancer and Liver Metastases: a Single-center, Single-arm, Phase 2 Trial
A single-center, single-arm, phase 2 trial of Serplulimab in combination with Regorafenib and hepatic artery bicarbonate infusion for third-line treatment in patients with colorectal cancer and liver metastases. A total of 30 patients are planned to be enrolled.
Read the detailed description
This is a single-center, single-arm, phase 2 trial. Enroll 30 patients with colorectal cancer and liver metastases and failure of standard therapy. Administer serplulimab intravenously(once every two weeks)in combination with regorafenib(from the first day to the 21th day) and hepatic artery bicarbonate infusion (once every four weeks). Medication must be discontinued until disease progression, intolerable toxicity, informed consent is withdrawn, or investigator judgment is made. The primary endpoint is objective response rate (ORR), and secondary endpoints are progression-free survival (PFS), overall survival (OS), and adverse effects (AE).
- Conditions
- Colorectal Cancer, Liver Metastases
- Being tested
- Serplulimab+Regorafenib, Hepatic Artery Bicarbonate Infusion
- Keywords
- Colorectal Cancer, Regorafenib, hepatic artery bicarbonate infusion, Serplulimab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serplulimab+RegorafenibDrug
Serplulimab: once every two weeks; Regorafenib: from the first day to the 21st day
Hepatic Artery Bicarbonate InfusionDrug
hepatic artery bicarbonate infusion: once every four weeks
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab in combination with Regorafenib and hepatic artery bicarbonate infusion | Experimental | Serplulimab: once every two weeks; Regorafenib: from the first day to the 21th day; hepatic artery bicarbonate infusion: once every four weeks Receives: Drug: Serplulimab+Regorafenib; Drug: Hepatic Artery Bicarbonate Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective Response Rate was defined as the proportion of patients with a best objective response of complete response (CR) or partial response (PR) according to RECIST criteria (version 1.1).
Measured: From Baseline to disease progress, up to 18 months
Secondary outcomes (3)
Adverse Events and Serious Adverse Events
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.
Measured: From Baseline to primary completion date, about 2 years
Progression free survival
Progression-free survival is defined as the time from enrollment to the first documented disease progression according to RECIST version 1.1, or to death from any cause, whichever occurred first
Measured: From Baseline to primary completion date, about 2 years
Overal survival
Time from randomization to death (from any cause)
Measured: From Baseline to primary completion date, about 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Yuan, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894837
- Sponsor's protocol ID
- 2023-034
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serplulimab in Combination With Regorafenib and Hepatic Artery Bicarbonate Infusion for Third-line Treatment in Patients With Colorectal Cancer and Liver Metastases: a Single-center, Single-arm, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT05894837
- Acronym / sponsor ID
- 2023-034
- Conditions
- Colorectal Cancer, Liver Metastases
- Keywords
- Colorectal Cancer, Regorafenib, hepatic artery bicarbonate infusion, Serplulimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 8 Jun 2023 (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.
A single-center, single-arm, phase 2 trial of Serplulimab in combination with Regorafenib and hepatic artery bicarbonate infusion for third-line treatment in patients with colorectal cancer and liver metastases. A total of 30 patients are planned to be enrolled.
Detailed description
This is a single-center, single-arm, phase 2 trial. Enroll 30 patients with colorectal cancer and liver metastases and failure of standard therapy. Administer serplulimab intravenously(once every two weeks)in combination with regorafenib(from the first day to the 21th day) and hepatic artery bicarbonate infusion (once every four weeks). Medication must be discontinued until disease progression, intolerable toxicity, informed consent is withdrawn, or investigator judgment is made. The primary endpoint is objective response rate (ORR), and secondary endpoints are progression-free survival (PFS), overall survival (OS), and adverse effects (AE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serplulimab in combination with Regorafenib and hepatic artery bicarbonate infusion | Experimental | Drug: Serplulimab+Regorafenib, Drug: Hepatic Artery Bicarbonate InfusionSerplulimab: once every two weeks; Regorafenib: from the first day to the 21th day; hepatic artery bicarbonate infusion: once every four weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 or above, male or female;
- Patients with colorectal cancer and liver metastases who strictly conform to the clinical diagnostic criteria of "Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer (2020 Edition)" or who have been confirmed by histopathology or cytology;
- At least 1 measurable intrahepatic lesion;
- Child-Pugh liver function rating: A or good B (≤7 points) ;
- No local treatment including radiotherapy, surgical excision and ablation was performed before interventional therapy;
Key exclusion criteria (15 listed)
- There is a contraindication of anti-PD-1 monoclonal antibody therapy;
- With other uncured malignancies, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ;
- Patients who are preparing for an organ transplant or have had an organ transplant in the past；
- Ascites with clinical symptoms that require therapeutic abdominal puncture or drainage, or Child-Pugh score > 2；
- Patients with high blood pressure (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg) who cannot be reduced to the normal range by antihypertensive medication；
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 |
|---|---|---|
| Serplulimab+RegorafenibSerplulimab: once every two weeks; Regorafenib: from the first day to the 21st day | Drug | Serplulimab in combination with Regorafenib and hepatic artery bicarbonate infusion |
| Hepatic Artery Bicarbonate Infusionhepatic artery bicarbonate infusion: once every four weeks | Drug | Serplulimab in combination with Regorafenib and hepatic artery bicarbonate infusion |
Primary outcome
Objective Response Rate
Time frame: From Baseline to disease progress, up to 18 months
Objective Response Rate was defined as the proportion of patients with a best objective response of complete response (CR) or partial response (PR) according to RECIST criteria (version 1.1).
3 secondary outcomes
Adverse Events and Serious Adverse Events
Time frame: From Baseline to primary completion date, about 2 years
Progression free survival
Time frame: From Baseline to primary completion date, about 2 years
Overal survival
Time frame: From Baseline to primary completion date, about 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
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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.
Ying Yuan study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Serplulimab+Regorafenib and Hepatic Artery Bicarbonate Infusion in people with Colorectal Cancer and Liver Metastases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 15 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 8 Jun 2023. 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 Shanshan Weng (+86-13758118823, 2310053@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: From Baseline to disease progress, up to 18 months). 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 8 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.