Gastrointestinal CancerPhase 2NCT05225844
An Exploratory Trail of Camrelizumab Plus Apatinib Mesylate for Advanced Gastrointestinal
A Phase 2 study testing Camrelizumab and Apatinib Mesylate in people with Gastrointestinal Cancer and Immunotherapy, run by Harbin Medical University at 1 site in China.
Trial summary
At present, surgery, radiotherapy and chemotherapy are the main treatment methods for patients with advanced gastrointestinal cancer. Although targeted therapy has significantly improved the prognosis of patients, the mortality of patients has not been significantly reduced, so new treatment methods are urgently… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Cancer, Immunotherapy, Targeted Therapy
- What is being tested?
- Camrelizumab and Apatinib Mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Oct 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Diagnosed as gastric or colorectal adenocarcinoma by histopathology and/or cytology.
- 2. Patients could not receive surgical resection. 3. Previous standard treatment failure . 4. According to the RECIST v1.1 guide, at least 1 lesions (never received radiotherapy),accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent as the first choice),the longest diameter was more than 10mm (except for the lymph nodes, the short axis of the lymph nodes must be more than 15mm), repeated measurement.
- 5.Eastern Cooperative Oncology Group Performance Status(ECOG PS):0-1 score 6.The main organs function is normal, which meets the following requirements. (1) Blood routine examination,(no blood transfusion within 14 days).
- Hemoglobin(HB)≥90g/L;
- Absolute neutrophil count (ANC) ≥1.5×10^9/L;
- Blood platelet (PLT)≥80×10^9/L; (2) Biochemical examination should comply with the following criteria:
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- Bilirubin(BIL) <1.5 times of the upper limit of normal value (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase(AST)<2.5*ULN (liver metastasis ALT and AST<5*ULN).
- Serum Cr≤1*ULN, creatinine clearance rate≥50ml/min(Cockcroft-Gault formula) 7. The expected survival time more than 3 months; 8. The physicians plan to use Camrelizumab Plus Apatinib Mesylate. 9. Patients voluntarily joined the study and signed informed consent form(ICF). 10. Childbearing age women must undergo a negative pregnancy test(serum or urine) within 7 days ,and voluntarily adopt appropriate methods for contraception from the period of under observation and within 8 weeks of the last time they are given the drug;As for men, it is necessary to receive surgical sterilization, or agree to adopt appropriate methods for contraception from the period of under observation and within 8 weeks of the last time they are given the drug.
Who cannot join
- There is a case of heart disease in any of the following situations. (1)Recent publications have the following heart disease (within 6 months)
- Acute coronary artery syndrome
- Acute heart failure (grade III or IV of NYHA classification)
- Significant ventricular arrhythmia(sustained ventricular tachycardia, ventricular fibrillation and sudden death after resuscitation).
- (2)The New York Heart Association(NYHA) grade of grade III or IV (3)The patients with severe conduction block, and permanent pacemaker is invalid (two degree and three degree atrioventricular block, sinus arrest) (4)Unexplained syncope occurred within 3 months.
- (5)The researchers identified as uncontrol of severe hypertension, or symptomatic hypertension.
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- There are many factors that affect the absorption of oral drugs (such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction).
- ECOG score≥2
- Abnormal coagulation function (INR>1.5*ULN, Activated Partial Thromboplastin Time (APTT)>1.5*ULN), with bleeding tendency.
- There is any history of allergy or hypersensitivity in this research's drug or adjuvant.
- HIV infection and/or active hepatitis B virus infection.
- Any condition that may damage the safety of patients or the integrity of research data, including serious medical risk factors, physical condition and laboratory abnormality.
- The high risk population carrying UGT1A1*28 (7/7) *6 (A/A) genotype or simultaneous carrying of the UGT1A1*28 (6/7) *6 (A/G) genotype (the heterozygous genotype) suggests the exclusion of the Irinotecan
- Pregnant or lactating women;
- Other conditions which the doctor think not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Harbin Medical University
Harbin, Heilongjiang
Yu Han, doctor
About this study
Official title: Camrelizumab Plus Apatinib Mesylate for Advanced Gastrointestinal Cancer With Previous Standard Treatment Failure ：an Exploratory, Single-arm, Open-label, Phase II Trial
At present, surgery, radiotherapy and chemotherapy are the main treatment methods for patients with advanced gastrointestinal cancer. Although targeted therapy has significantly improved the prognosis of patients, the mortality of patients has not been significantly reduced, so new treatment methods are urgently needed. In recent years, immunotherapy has become a new hotspot in tumor therapy. Compared with traditional treatment, immune checkpoint inhibitors (ICIS) have shown long-term good efficacy and tolerance in clinical trials. However, single drug ICIS has reached a bottleneck for advanced gastrointestinal cancer, with low response rate and poor PFS and OS. With the results of REGONIVO showing good efficacy, the treatment mode of immune combined with small molecule anti angiogenesis drugs has sprung up. The purpose of this study was to analyze the efficacy and safety of in Camrelizumab combination with Apatinib mesylate in advanced gastrointestinal cancer.
- Conditions
- Gastrointestinal Cancer, Immunotherapy, Targeted Therapy
- Being tested
- Camrelizumab, Apatinib Mesylate
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Camrelizumab ，200mg/㎡，d1，ivgtt，every 21 days as a cycle
Apatinib MesylateDrug
Apatinib Mesylate，250mg/㎡，po，d1-5 on/d2 off，every 21 days as a cycle
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab Plus Apatinib mesylate | Experimental | for advanced gastric cancer with previous standard treatment failure Receives: Drug: Camrelizumab; Drug: Apatinib Mesylate |
| Camrelizumab and Apatinib mesylate | Experimental | for advanced colorectal cancer with previous standard treatment failure Receives: Drug: Camrelizumab; Drug: Apatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.
Measured: 24 months
progression-free survival（PFS）
the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)
Measured: 24 months
Secondary outcomes (3)
Overall Survival（OS）
overall survival time after the beginning of the treatment
Measured: 24 months
Adverse Events
Adverse events will be evaluated according to NCI CTCAE 4.0
Measured: 24 months
Disease control rate(DCR)
The rate of cases of remission and stable disease accounts for the total evaluable cases after treatment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Jan 2019
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Han, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225844
- Sponsor's protocol ID
- 2022-1-23
- Status last verified
- Feb 2022
- First submitted
- 24 Jan 2022
- Last updated
- 7 Feb 2022
- 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 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Plus Apatinib Mesylate for Advanced Gastrointestinal Cancer With Previous Standard Treatment Failure ：an Exploratory, Single-arm, Open-label, Phase II Trial
- ClinicalTrials.gov ID
- NCT05225844
- Acronym / sponsor ID
- 2022-1-23
- Conditions
- Gastrointestinal Cancer, Immunotherapy, Targeted Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 7 Feb 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.
At present, surgery, radiotherapy and chemotherapy are the main treatment methods for patients with advanced gastrointestinal cancer. Although targeted therapy has significantly improved the prognosis of patients, the mortality of patients has not been significantly reduced, so new treatment methods are urgently needed. In recent years, immunotherapy has become a new hotspot in tumor therapy. Compared with traditional treatment, immune checkpoint inhibitors (ICIS) have shown long-term good efficacy and tolerance in clinical trials. However, single drug ICIS has reached a bottleneck for advanced gastrointestinal cancer, with low response rate and poor PFS and OS. With the results of REGONIVO showing good efficacy, the treatment mode of immune combined with small molecule anti angiogenesis drugs has sprung up. The purpose of this study was to analyze the efficacy and safety of in Camrelizumab combination with Apatinib mesylate in advanced gastrointestinal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab Plus Apatinib mesylate | Experimental | Drug: Camrelizumab, Drug: Apatinib Mesylatefor advanced gastric cancer with previous standard treatment failure |
| Camrelizumab and Apatinib mesylate | Experimental | Drug: Camrelizumab, Drug: Apatinib Mesylatefor advanced colorectal cancer with previous standard treatment failure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Diagnosed as gastric or colorectal adenocarcinoma by histopathology and/or cytology.
- 2. Patients could not receive surgical resection. 3. Previous standard treatment failure . 4. According to the RECIST v1.1 guide, at least 1 lesions (never received radiotherapy),accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent as the first choice),the longest diameter was more than 10mm (except for the lymph nodes, the short axis of the lymph nodes must be more than 15mm), repeated measurement.
- 5.Eastern Cooperative Oncology Group Performance Status(ECOG PS):0-1 score 6.The main organs function is normal, which meets the following requirements. (1) Blood routine examination,(no blood transfusion within 14 days).
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Key exclusion criteria (15 listed)
- There is a case of heart disease in any of the following situations. (1)Recent publications have the following heart disease (within 6 months)
- (2)The New York Heart Association(NYHA) grade of grade III or IV (3)The patients with severe conduction block, and permanent pacemaker is invalid (two degree and three degree atrioventricular block, sinus arrest) (4)Unexplained syncope occurred within 3 months.
- (5)The researchers identified as uncontrol of severe hypertension, or symptomatic hypertension.
- There are many factors that affect the absorption of oral drugs (such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction).
- ECOG score≥2
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 |
|---|---|---|
| CamrelizumabCamrelizumab ，200mg/㎡，d1，ivgtt，every 21 days as a cycle | Drug | Camrelizumab Plus Apatinib mesylate, Camrelizumab and Apatinib mesylate |
| Apatinib MesylateApatinib Mesylate，250mg/㎡，po，d1-5 on/d2 off，every 21 days as a cycle | Drug | Camrelizumab Plus Apatinib mesylate, Camrelizumab and Apatinib mesylate |
Primary outcome
Objective response rate (ORR)
Time frame: 24 months
The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.
progression-free survival（PFS）
Time frame: 24 months
the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)
3 secondary outcomes
Overall Survival（OS）
Time frame: 24 months
Adverse Events
Time frame: 24 months
Disease control rate(DCR)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 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 and Apatinib Mesylate in people with Gastrointestinal Cancer and Immunotherapy, run by Harbin Medical 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 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 7 Feb 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 Yu Han, doctor (+86-451-86298303, hanyuemail@163.com), 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: 24 months). The study lists 2 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 7 Feb 2022.