Colorectal NeoplasmsPhase 2NCT05193292
Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer
A Phase 2 study testing Camrelizumab, Trastuzumab and XELOX regimen in people with Colorectal Neoplasms and Intestinal Neoplasms, run by Fudan University at 1 site in China.
Trial summary
This study aimed to evaluate the efficacy and safety of camrelizumab combined with trastuzumab and chemotherapy in Patients with HER2-positive advanced colorectal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Intestinal Neoplasms
- What is being tested?
- Camrelizumab, Trastuzumab and XELOX regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- Jan 2022to Jan 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
- Subjects has voluntarily agreed to sign the informed consent and have good compliance and are willing to cooperate with follow-up.
- Age 18 years or older, male or female.
- Have a life expectancy of at least 3 months.
- Histologically confirmed diagnosis of unresectable recurrent or metastatic HER2 positive colorectal cancer.
- HER2 positivity defined as the colorectal cancer-specific HERACLES diagnostic criteria or NGS sequencing of tumor tissue/blood samples showed HER2 amplification.
- Patients have not received systemic anti-cancer treatment in the past or had disease progression more than 6 months after receiving after (neo)adjuvant treatment could be enrolled or failure of first-line therapy or completion of (new) adjuvant therapy to disease recurrence less than 6 months.
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- At least one measurable or evaluable lesion, as defined by RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- The functional level of the major organs must meet the following requirements:(1)Blood routine: neutrophils (ANC) ≥1.5×10^9/L; platelet count (PLT)≥90×10^9/L; hemoglobin (Hb) ≥90 g/L; (2)Blood biochemistry: TBIL≤1.5×ULN; ALT and AST≤2.5×ULN; Cr≤1.5×ULN and creatinine clearance≥50 mL/min (Cockcroft-Gault formula); for subjects with liver metastasis: TBIL≤3×ULN; ALT and AST≤5×ULN; (3)Patients was not receiving anticoagulation therapy (INR ≤ 1.5 or aPTT ≤ 1.5 × ULN). If the patient received prophylactic anticoagulation therapy and the INR ≤ 2 × ULN within 14 days before the start of the study and the aPTT/PPT is within the normal range could be enrolled; (4)Left ventricular ejection fraction (LVEF) ≥55% (within 28 days).
- Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the treatment period.
Who cannot join
- Have previously received any co-stimulatory or co-inhibitory T cell receptor antibody or drug therapy, including PD-1, PD-L1, PD-L2, CD137, CTLA-4, etc.
- Have previously received anti-HER2 targeted therapy (monoclonal antibody or small molecule TKI).
- Have any active autoimmune diseases or autoimmune diseases in the past 2 years.
- Have used immunosuppressive drugs within 4 weeks before the first dose of study drug treatment.
- Allergic to any monoclonal antibody or chemotherapeutic drug preparation component.
- Receive a live attenuated vaccine within 4 weeks before the first dose of study drug treatment.
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- Known symptomatic central nervous system metastases and/or cancerous meningitis. If subjects with brain metastases who have been treated in the past are in stable condition, they could be enrolled.
- Pleural and abdominal effusion requiring clinical treatment, or third interspace effusion.
- Suffering from congenital or acquired immune deficiency.
- Known history of human immunodeficiency virus (HIV) infection.
- Subjects who have received allogeneic tissue/solid organ transplantation.
- Known to have active tuberculosis.
- Known to have acute or chronic active hepatitis B or acute or chronic active hepatitis C.
- Severe infections that are active or poorly clinical controlled.
- Known history of (non-infectious) pneumonia requiring steroid treatment or currently suffering from pneumonia.
- Other poorly controlled comorbidities.
- Pregnancy or breastfeeding or planning to pregnancy or childbirth during the study period.
- Have uncontrolled cardiac clinical symptoms or diseases.
- Malignant tumors that are progressing or require active treatment in the past 5 years, except for the following: (1) Malignant tumors that have been completely relieved for at least 2 years before enrollment and no other treatment is required during the study period; (2) Non-melanoma skin cancer or malignant freckle-like nevus that has been adequately treated and has no evidence of disease recurrence; (3) Carcinoma in situ with adequate treatment and no evidence of disease recurrence.
- According to the judgment of the investigator, the patient has other factors that may affect the results of the study or cause the study to be terminated halfway.
Trial locations and contacts
1 site in 1 country.
China1 site
270 Dongan Road, Fudan University Shanghai Cancer Center
Shanghai, 200032
About this study
Official title: Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer: A Prospective, Single-arm, Open-label Study
This study aimed to evaluate the efficacy and safety of camrelizumab combined with trastuzumab and chemotherapy in Patients with HER2-positive advanced colorectal cancer
- Conditions
- Colorectal Neoplasms, Intestinal Neoplasms
- Being tested
- Camrelizumab, Trastuzumab, XELOX regimen, mFOLFOX6 regimen, FOLFIRI regimen
- Medical subject headings
- Colorectal Neoplasms, Intestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
200mg, iv, 21d for a treatment cycle
TrastuzumabDrug
8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle
XELOX regimenDrug
Oxaliplatin, 130 mg/m2, iv, d1; Capecitabine, 1000 mg/m2, po, bid, d1-d14; q3w
mFOLFOX6 regimenDrug
Oxaliplatin, 85 mg/m2, iv, d1; Leucovorin, 400 mg/m2, iv, d1; 5-FU, 400mg/m2, iv, d1 followed by 1200 mg/(m2·d)*2d, civ, 46h; q2w
FOLFIRI regimenDrug
Irinotecan, 180 mg/m2, iv, d1; Leucovorin, 400 mg/m2, iv, d1; 5-FU, 400mg/m2, iv, d1 followed by 1200 mg/(m2·d)*2d, civ, 46h; q2w
mXELIRI regimenDrug
Irinotecan, 200 mg/m2, iv, d1; capecitabine, 800 mg/m2, po, bid, d1-d14; q3w
mIRIS regimenDrug
Irinotecan, 180 mg/m2, iv, d1; Tiggio Capsules (S-1), 40-60 mg/m2, po, bid, d1-d9; q2w
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab combined with trastuzumab and chemotherapy | Experimental | Camrelizumab: 200mg, iv, 21d for a treatment cycle Trastuzumab: 8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle Chemotherapy will either be XELOX, mFOLFOX6, FOLFIRI, mXELIRI or mIRIS Receives: Drug: Camrelizumab; Drug: Trastuzumab; Drug: XELOX regimen; Drug: mFOLFOX6 regimen; Drug: FOLFIRI regimen; Drug: mXELIRI regimen; Drug: mIRIS regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The proportion of patients with complete response or partial response according to RECIST v1.1
Measured: [ Time Frame: Approximately 24 months ]
Secondary outcomes (4)
Progression-Free Survival
Time from the initiation of treatment to disease progression or any-cause death
Measured: [ Time Frame: Approximately 24 months ]
Disease Control Rate
The proportion of patients with complete response, partial response or stable disease according to RECIST v1.1
Measured: [ Time Frame: Approximately 24 months ]
Overall Survival
Time from the initiation of treatment to any-cause death
Measured: [ Time Frame: Approximately 24 months ]
Duration of Response
Time from complete response or partial response to disease progression or any-cause death
Measured: [ Time Frame: Approximately 24 months ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fudan 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
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193292
- Sponsor's protocol ID
- FUSCC-CamreTrastumCRC
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2021
- Last updated
- 14 Jan 2022
- 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 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer: A Prospective, Single-arm, Open-label Study
- ClinicalTrials.gov ID
- NCT05193292
- Acronym / sponsor ID
- FUSCC-CamreTrastumCRC
- Conditions
- Colorectal Neoplasms, Intestinal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 14 Jan 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.
This study aimed to evaluate the efficacy and safety of camrelizumab combined with trastuzumab and chemotherapy in Patients with HER2-positive advanced colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab combined with trastuzumab and chemotherapy | Experimental | Drug: Camrelizumab, Drug: Trastuzumab, Drug: XELOX regimen, Drug: mFOLFOX6 regimen, Drug: FOLFIRI regimen, Drug: mXELIRI regimen, Drug: mIRIS regimenCamrelizumab: 200mg, iv, 21d for a treatment cycle Trastuzumab: 8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle Chemotherapy will either be XELOX, mFOLFOX6, FOLFIRI, mXELIRI or mIRIS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects has voluntarily agreed to sign the informed consent and have good compliance and are willing to cooperate with follow-up.
- Age 18 years or older, male or female.
- Have a life expectancy of at least 3 months.
- Histologically confirmed diagnosis of unresectable recurrent or metastatic HER2 positive colorectal cancer.
- HER2 positivity defined as the colorectal cancer-specific HERACLES diagnostic criteria or NGS sequencing of tumor tissue/blood samples showed HER2 amplification.
Key exclusion criteria (20 listed)
- Have previously received any co-stimulatory or co-inhibitory T cell receptor antibody or drug therapy, including PD-1, PD-L1, PD-L2, CD137, CTLA-4, etc.
- Have previously received anti-HER2 targeted therapy (monoclonal antibody or small molecule TKI).
- Have any active autoimmune diseases or autoimmune diseases in the past 2 years.
- Have used immunosuppressive drugs within 4 weeks before the first dose of study drug treatment.
- Allergic to any monoclonal antibody or chemotherapeutic drug preparation component.
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 |
|---|---|---|
| Camrelizumab200mg, iv, 21d for a treatment cycle | Drug | Camrelizumab combined with trastuzumab and chemotherapy |
| Trastuzumab8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle | Drug | Camrelizumab combined with trastuzumab and chemotherapy |
| XELOX regimenOxaliplatin, 130 mg/m2, iv, d1; Capecitabine, 1000 mg/m2, po, bid, d1-d14; q3w | Drug | Camrelizumab combined with trastuzumab and chemotherapy |
| mFOLFOX6 regimenOxaliplatin, 85 mg/m2, iv, d1; Leucovorin, 400 mg/m2, iv, d1; 5-FU, 400mg/m2, iv, d1 followed by 1200 mg/(m2·d)*2d, civ, 46h; q2w | Drug | Camrelizumab combined with trastuzumab and chemotherapy |
| FOLFIRI regimenIrinotecan, 180 mg/m2, iv, d1; Leucovorin, 400 mg/m2, iv, d1; 5-FU, 400mg/m2, iv, d1 followed by 1200 mg/(m2·d)*2d, civ, 46h; q2w | Drug | Camrelizumab combined with trastuzumab and chemotherapy |
| mXELIRI regimenIrinotecan, 200 mg/m2, iv, d1; capecitabine, 800 mg/m2, po, bid, d1-d14; q3w | Drug | Camrelizumab combined with trastuzumab and chemotherapy |
| mIRIS regimenIrinotecan, 180 mg/m2, iv, d1; Tiggio Capsules (S-1), 40-60 mg/m2, po, bid, d1-d9; q2w | Drug | Camrelizumab combined with trastuzumab and chemotherapy |
Primary outcome
Objective Response Rate
Time frame: [ Time Frame: Approximately 24 months ]
The proportion of patients with complete response or partial response according to RECIST v1.1
4 secondary outcomes
Progression-Free Survival
Time frame: [ Time Frame: Approximately 24 months ]
Disease Control Rate
Time frame: [ Time Frame: Approximately 24 months ]
Overall Survival
Time frame: [ Time Frame: Approximately 24 months ]
Duration of Response
Time frame: [ Time Frame: Approximately 24 months ]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
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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.
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 Camrelizumab, Trastuzumab and XELOX regimen in people with Colorectal Neoplasms and Intestinal Neoplasms, run by Fudan 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 10 inclusion and 20 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 14 Jan 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 Zhe Zhang, PHD (8621-64175590, zhangzhe2010fduscc@gmail.com), 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: [ Time Frame: Approximately 24 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 14 Jan 2022.