Colorectal Cancer (CRC)NCT06751914
Neoantigen-based Peptide Vaccine and Conventional Second-line Therapy for CRC Progressed After First-line Treatment
A study testing Conventional second-line therapy and Neoantigen-based peptide vaccine in people with Colorectal Cancer (CRC), run by The First Affiliated Hospital of Nanchang University at 2 sites in China.
Trial summary
In this study, the investigators provide a combined treatment of personalized tumor neoantigen-based peptide vaccine and conventional second-line therapy to patients with colorectal cancer (CRC) progressed after first-line treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- Conventional second-line therapy and Neoantigen-based peptide vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed CRC;
- At least one measurable lesion;
- Aged 18-70, regardless of gender;
- Disease progression after standard first-line therapy, and more than 2 weeks since the end of the last antitumor treatment;
- Expected survival of ≥3 months;
- ECOG performance status of 0-1;
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- Female patients of childbearing age must have a negative pregnancy test and be able to take effective contraceptive measures with no plans for pregnancy within six months of the study;
- Able to undergo all screening period laboratory tests as required by the protocol;
- Normal major organ function, such as heart, liver, and kidney;
- Hematologic parameters: neutrophil count ≥1.5×10^9/L, hemoglobin ≥10g/dL, platelet count ≥100×10^9/L, total bilirubin ≤1.5 times the upper limit of normal, AST and ALT ≤2.5 times the upper limit of normal, creatinine and blood urea nitrogen ≤1.5 times the upper limit of normal, activated partial thromboplastin time ≤1.5×ULN, and International Normalized Ratio or prothrombin time ≤1.5×ULN;
- No active hepatitis, AIDS, syphilis, or other infectious diseases;
- Rheumatoid panel: C-reactive protein (CRP) ≤10.0mg/L; Anti-streptolysin O (ASO) <500U; Erythrocyte sedimentation rate ≤15mm/h (men) or 20mm/h (women);
- Thyroid function tests: 0.27mIU/L ≤ Thyroid-stimulating hormone (TSH) ≤ 4.2mIU/L; 3.1pmol/L ≤ Free triiodothyronine (FT3) ≤ 6.8pmol/L; 12pmol/L ≤ Serum free thyroxine (FT4) ≤ 22pmol/L; 1.3nmol/L ≤ Serum total triiodothyronine (TT3) ≤ 3.1nmol/L; 66nmol/L ≤ Serum total thyroxine (TT4) ≤ 181nmol/L;
- Adrenocorticotropic hormone (ACTH): 1.1-17.6pmol/L;
- Ability to understand and voluntarily sign a written informed consent form.
Who cannot join
- Disease-specific exclusion criteria:
- Patients with uncontrollable brain metastases;
- Subjects expected to require any form of antitumor treatment during the study, including maintenance therapy with other drugs, chemotherapy, and/or surgical resection.
- Subjects who have required systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressants within 14 days before the first dose. Inhalational or topical corticosteroids are allowed in the absence of active autoimmune diseases;
- Subjects who have been treated with anticancer immunotherapies or other immunostimulatory anticancer drugs (interferons, interleukins, thymosin, immune cell therapy, etc.) within 3 months before the first dose;
- Subjects participating in other clinical trials or whose first dose is less than 4 weeks (or 5 half-lives of the study drug) after the end of the previous clinical trial (last dose);
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- Subjects with severe cardiovascular diseases, such as those meeting NYHA Class II or higher criteria, myocardial infarction, or cerebrovascular accidents (cerebral ischemia, symptomatic cerebral embolism, etc.) occurring within 3 months before the first dose, or unstable arrhythmias or unstable angina within 1 month before starting study treatment;
- Subjects with uncontrolled myocardial ischemia or myocardial infarction, poorly controlled arrhythmias are excluded;
- Subjects with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg) (Note: a stable antihypertensive regimen should be in place within 1 week before the first dose);
- Subjects who have had significant clinically relevant bleeding symptoms or a clear bleeding tendency within 3 months before the first dose, as well as tumors that have invaded major blood vessels or, in the investigator's judgment, are highly likely to invade major blood vessels and cause major bleeding during treatment. Subjects with obvious hemoptysis, coughing up 2.5 mL or more of blood in the month before the first dose;
- Subjects who have experienced arterial/venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism), deep vein thrombosis, and pulmonary embolism, within 3 months before screening;
- Subjects with active tuberculosis;
- Subjects who have had a serious infection within 4 weeks before the first dose, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.; Subjects with any active infection;
- Subjects preparing for or who have previously undergone tissue/organ transplantation;
- Subjects with uncontrolled epilepsy, central nervous system disorders, or neurological diseases resulting in cognitive impairment;
- Subjects with a history of splenectomy.
- Other exclusion criteria:
- Pregnant or breastfeeding women;
- Subjects with a severe history of allergies or atopic constitution;
- Subjects with a history of chronic alcohol or drug abuse within 6 months before enrollment;
- Subjects deemed unsuitable for the study by the investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Yong Li, MD, 15879155066, Liyongcsco@email.ncu.edu.cn
- Recruiting
The First Hospital of Nanchang
Nanchang, Jiangxi, 330006
Jun Xu, MD, 13970928764, xujun0202118@163.com
About this study
Official title: A Multicenter Clinical Study of Personalized Tumor Neoantigen-based Peptide Vaccine Combined with Conventional Second-line Therapy for the Treatment of Colorectal Cancer Progressed After First-line Treatment
In this study, the investigators provide a combined treatment of personalized tumor neoantigen-based peptide vaccine and conventional second-line therapy to patients with colorectal cancer (CRC) progressed after first-line treatment. The investigators observe the objective response rate (ORR), disease control rate (DCR), adverse event (AE), serious adverse event (SAE), progression-free survival (PFS), and overall survival (OS) , aiming to evaluate the effectiveness and safety of the treatment.
Read the detailed description
This study is conducted in accordance with the Declaration of Helsinki and the guidelines of the Consolidated Standards of Reporting Trials.
10 patients with CRC progressed after first-line therapy will be recruited in this study. With doctor's assessment, a combined treatment of conventional second-line therapy and personalized tumor neoantigen-based peptide vaccine treatment plan will be designed for each participant.
Here are the steps for preparing the neoantigen-based peptide vaccine:
Collecting venous blood samples; Blood PBMC exome sequencing; RNA transcriptome sequencing; Classifying HLA alleles; Performing bioinformatics analysis, finding meaningful mutations and about 20 neoantigen sequences for each patient; Synthesizing peptide neoantigens; Preparation of the personalized tumor neoantigen-based peptide vaccine.
Participants will receive a conventional second-line therapy course and 10 subcutaneous injections of the vaccine within a treatment period of 21 weeks. After treatment, participants will be followed in every 6 weeks till the end of the study. Venous blood collection, physical examination, ECOG Performance Status Scale assessment, CT/MRI scan, X-ray examination, laboratory examination, and other necessary examinations are required at each follow-up visit.
- Conditions
- Colorectal Cancer (CRC)
- Being tested
- Conventional second-line therapy, Neoantigen-based peptide vaccine
- Keywords
- Tumor Neoantigen, Peptide Vaccine, Colorectal Cancer (CRC), Immunotherapy, Second-line Therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional second-line therapyCombination product
Conventional second-line therapy includes chemotherapy, targeted cancer drugs, and/or PD-1 inhibitors.The chemotherapy drugs, dosage and treatment cycle are determined by the subject's attending physician based on the subject's specific conditions. The medication, dosage and treatment cycle of targeted cancer drugs will be determined by the subject's attending physician based on the subject's specific circumstances. The PD-1 inhibitor treatment cycle is 3 weeks, and the drug is administered by intravenous infusion on the first day (D1) of each treatment cycle. The dosage is based on the instructions.
Neoantigen-based peptide vaccineDrug
The treatment with personalized tumor neoantigen-based peptide vaccine is divided into two periods: the primary phase and the boost phase. The primary phase consists of 6 treatments, with the first 3 treatments spaced one week apart and the subsequent 3 treatments spaced two weeks apart. Vaccine will be administrated on the fourth day (D4) of that week. The boost phase consists of 4 treatments, each spaced three weeks apart. Vaccine will be administrated on the fourth day (D4) of that week.
| Study group | Role | What they receive |
|---|---|---|
| Combinational treatment of conventional second-line therapy and neoantigen-based peptide vaccine | Experimental | Participants will receive a conventional second-line therapy and 10 subcutaneous injections of the vaccine within a treatment period of 21 weeks. Receives: Combination Product: Conventional second-line therapy; Drug: Neoantigen-based peptide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
According to RECIST (version 1.1) criteria, the proportion of subjects experiencing Complete Response (CR) or Partial Response (PR) within the analyzed population. Provide the 95% CI for the Objective Response Rate (ORR).
Measured: Through study completion, an average of 30 weeks
Disease control rate (DCR)
According to RECIST (version 1.1) criteria, the proportion of subjects experiencing Complete Response (CR), Partial Response (PR), or Stable Disease (SD) within the analyzed population. Provide the 95% CI for the Disease Control Rate (DCR).
Measured: Through study completion, an average of 30 weeks
Drug safety
Safety analysis will be based on data from the safety population. It will primarily involve descriptive statistical analysis, with tables describing the adverse events that occurred in this study.
Measured: Through study completion, an average of 30 weeks
Secondary outcomes (2)
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from the first administration of the study drug to disease progression or death. For subjects who have not reported disease progression at the time of analysis, the date of their last disease progression-free check will be used as the censoring date. The median PFS and its 95% CI will be analyzed using the Kaplan-Meier method, and survival curves will be plotted.
Measured: From date of recruiting until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 66 months
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the first administration of the study drug to death from any cause. For subjects who have not reported death at the time of analysis, the date of their last known survival will be used as the censoring date. The median OS and its 95% CI will be analyzed using the Kaplan-Meier method, and survival curves will be plotted.
Measured: From date of recruiting until the date of death from any cause, whichever came first, assessed up to 66 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start1 Sep 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751914
- Sponsor's protocol ID
- ISL2024311
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study of Personalized Tumor Neoantigen-based Peptide Vaccine Combined with Conventional Second-line Therapy for the Treatment of Colorectal Cancer Progressed After First-line Treatment
- ClinicalTrials.gov ID
- NCT06751914
- Acronym / sponsor ID
- ISL2024311
- Conditions
- Colorectal Cancer (CRC)
- Keywords
- Tumor Neoantigen, Peptide Vaccine, Colorectal Cancer (CRC), Immunotherapy, Second-line Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 30 Dec 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.
In this study, the investigators provide a combined treatment of personalized tumor neoantigen-based peptide vaccine and conventional second-line therapy to patients with colorectal cancer (CRC) progressed after first-line treatment. The investigators observe the objective response rate (ORR), disease control rate (DCR), adverse event (AE), serious adverse event (SAE), progression-free survival (PFS), and overall survival (OS) , aiming to evaluate the effectiveness and safety of the treatment.
Detailed description
This study is conducted in accordance with the Declaration of Helsinki and the guidelines of the Consolidated Standards of Reporting Trials.
10 patients with CRC progressed after first-line therapy will be recruited in this study. With doctor's assessment, a combined treatment of conventional second-line therapy and personalized tumor neoantigen-based peptide vaccine treatment plan will be designed for each participant.
Here are the steps for preparing the neoantigen-based peptide vaccine:
Collecting venous blood samples; Blood PBMC exome sequencing; RNA transcriptome sequencing; Classifying HLA alleles; Performing bioinformatics analysis, finding meaningful mutations and about 20 neoantigen sequences for each patient; Synthesizing peptide neoantigens; Preparation of the personalized tumor neoantigen-based peptide vaccine.
Participants will receive a conventional second-line therapy course and 10 subcutaneous injections of the vaccine within a treatment period of 21 weeks. After treatment, participants will be followed in every 6 weeks till the end of the study. Venous blood collection, physical examination, ECOG Performance Status Scale assessment, CT/MRI scan, X-ray examination, laboratory examination, and other necessary examinations are required at each follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combinational treatment of conventional second-line therapy and neoantigen-based peptide vaccine | Experimental | Combination Product: Conventional second-line therapy, Drug: Neoantigen-based peptide vaccineParticipants will receive a conventional second-line therapy and 10 subcutaneous injections of the vaccine within a treatment period of 21 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with histologically or cytologically confirmed CRC;
- At least one measurable lesion;
- Aged 18-70, regardless of gender;
- Disease progression after standard first-line therapy, and more than 2 weeks since the end of the last antitumor treatment;
- Expected survival of ≥3 months;
Key exclusion criteria (21 listed)
- Patients with uncontrollable brain metastases;
- Subjects expected to require any form of antitumor treatment during the study, including maintenance therapy with other drugs, chemotherapy, and/or surgical resection.
- Subjects who have required systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressants within 14 days before the first dose. Inhalational or topical corticosteroids are allowed in the absence of active autoimmune diseases;
- Subjects who have been treated with anticancer immunotherapies or other immunostimulatory anticancer drugs (interferons, interleukins, thymosin, immune cell therapy, etc.) within 3 months before the first dose;
- Subjects participating in other clinical trials or whose first dose is less than 4 weeks (or 5 half-lives of the study drug) after the end of the previous clinical trial (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 |
|---|---|---|
| Conventional second-line therapyConventional second-line therapy includes chemotherapy, targeted cancer drugs, and/or PD-1 inhibitors.The chemotherapy drugs, dosage and treatment cycle are determined by the subject's attending physician based on the subject's specific conditions. The medication, dosage and treatment cycle of targeted cancer drugs will be determined by the subject's attending physician based on the subject's specific circumstances. The PD-1 inhibitor treatment cycle is 3 weeks, and the drug is administered by intravenous infusion on the first day (D1) of each treatment cycle. The dosage is based on the instructions. | Combination product | Combinational treatment of conventional second-line therapy and neoantigen-based peptide vaccine |
| Neoantigen-based peptide vaccineThe treatment with personalized tumor neoantigen-based peptide vaccine is divided into two periods: the primary phase and the boost phase. The primary phase consists of 6 treatments, with the first 3 treatments spaced one week apart and the subsequent 3 treatments spaced two weeks apart. Vaccine will be administrated on the fourth day (D4) of that week. The boost phase consists of 4 treatments, each spaced three weeks apart. Vaccine will be administrated on the fourth day (D4) of that week. | Drug | Combinational treatment of conventional second-line therapy and neoantigen-based peptide vaccine |
Primary outcome
Objective response rate (ORR)
Time frame: Through study completion, an average of 30 weeks
According to RECIST (version 1.1) criteria, the proportion of subjects experiencing Complete Response (CR) or Partial Response (PR) within the analyzed population. Provide the 95% CI for the Objective Response Rate (ORR).
Disease control rate (DCR)
Time frame: Through study completion, an average of 30 weeks
According to RECIST (version 1.1) criteria, the proportion of subjects experiencing Complete Response (CR), Partial Response (PR), or Stable Disease (SD) within the analyzed population. Provide the 95% CI for the Disease Control Rate (DCR).
Drug safety
Time frame: Through study completion, an average of 30 weeks
Safety analysis will be based on data from the safety population. It will primarily involve descriptive statistical analysis, with tables describing the adverse events that occurred in this study.
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From date of recruiting until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 66 months
Overall Survival (OS)
Time frame: From date of recruiting until the date of death from any cause, whichever came first, assessed up to 66 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional second-line therapy and Neoantigen-based peptide vaccine in people with Colorectal Cancer (CRC), run by The First Affiliated Hospital of Nanchang University at 2 sites 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 15 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Li, MD (15879155066, Liyongcsco@email.ncu.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 (ORR) (time frame: Through study completion, an average of 30 weeks). The study lists 3 primary outcomes in all. 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 30 Dec 2024.