Advanced Solid TumorPhase 2NCT04282278
Study of Anti-PD-1 Antibody Multimodal Combination as First-line Treatment on Time Window of Advanced Solid Tumor
A Phase 2 study testing Camrelizumab/sintilimab+ Standard chemotherapy, Camrelizumab/sintilimab+ apatinib（Intolerance to chemotherapy / refuse chemotherapy） and Camrelizumab/sintilimab+ apatinib+ Standard chemotherapy in people with Advanced Solid Tumor, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess time window, efficacy and safety of patients who receive anti-PD-1 antibody multimodal combination as first-line treatment of advanced solid tumor. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Camrelizumab/sintilimab+ Standard chemotherapy, Camrelizumab/sintilimab+ apatinib（Intolerance to chemotherapy / refuse chemotherapy） and Camrelizumab/sintilimab+ apatinib+ Standard chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2020to 1 Apr 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age:18 to 70 years old;
- Patients with advanced solid tumors confirmed by histopathology or cytology and genetic testing was negative;
- None previous chemotherapy, Antiangiogenic targeted therapy, Immune checkpoint inhibitors therapy（NOTE: neoadjuvant and adjuvant therapy is allowed）;
- At least one measurable lesion (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Life expectancy greater than or equal to 18 weeks;
- Major organ function has to meet the following certeria:
- 1) For results of blood routine test HB≥90g/L; ANC≥1.5×109/L; PLT≥90×109/L; 2) For results of blood biochemical test ALB≥30g/L ALT and AST<2.5×ULN, but<5×ULN if the transferanse elevation is due to liver metastases； TBIL≤1.5×ULN； Serum creatinine ≤1.5×ULN; 8. Left ventricular ejection fraction (LVEF) ≥50%; 9. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 14 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 10. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Who cannot join
- Patients with symptomatic brain metastases;
- Subjects with immunosuppressive medications within 14 days of first administration of study treatment, prednisone is used for less than 1 week, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose);
- The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, Hyperthyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
- Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ, dual or multiple primary tumors);
- Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA ≥1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study ;
- 3 months before study drug administration, the following occurred: myocardial infarction, severe / unstable angina pectoris, grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria, uncontrolled arrhythmias (including QTcF interval male> 450 ms, female> 470 ms ,The QTcF interval is calculated using Fridericia formula), symptomatic congestive heart failure, cerebrovascular accidents (including transient ischemic attack or symptomatic pulmonary embolism), in stable phase, need a cardiovascular physician evaluation;
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- Severe infections within 2 weeks before study drug administration (eg. Need intravenous drip antibiotics, antifungals or antivirals) or >38.5℃during screening visits or on the first scheduled day of dosing;
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Less than 4 weeks from the last clinical trial;
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- The researchers think inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Jian Shi
About this study
The purpose of this study is to assess time window, efficacy and safety of patients who receive anti-PD-1 antibody multimodal combination as first-line treatment of advanced solid tumor.
- Conditions
- Advanced Solid Tumor
- Being tested
- Camrelizumab/sintilimab+ Standard chemotherapy, Camrelizumab/sintilimab+ apatinib（Intolerance to chemotherapy / refuse chemotherapy）, Camrelizumab/sintilimab+ apatinib+ Standard chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab/sintilimab+ Standard chemotherapyDrug
Camrelizumab/sintilimab：200mg，iv，30min，d4，q3w，24 months Standard chemotherapy：Researcher chooses standard treatment by recommended guidelines，d 1-3
Camrelizumab/sintilimab+ apatinib（Intolerance to chemotherapy / refuse chemotherapy）Drug
Camrelizumab/sintilimab：200mg，iv，30min，d4，q3w，24 months Apatinib：250mg，d1，qd，po
Camrelizumab/sintilimab+ apatinib+ Standard chemotherapyDrug
Camrelizumab/sintilimab：200mg，iv，30min，d7，q3w，24 months Apatinib：250mg，d1，qd，po Standard chemotherapy：Researcher chooses standard treatment by recommended guidelines，d 1-3
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: Camrelizumab/sintilimab+ Standard chemotherapy |
| Group B | Experimental | Not described Receives: Drug: Camrelizumab/sintilimab+ apatinib（Intolerance to chemotherapy / refuse chemotherapy） |
| Group C | Experimental | Not described Receives: Drug: Camrelizumab/sintilimab+ apatinib+ Standard chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Baseline to measured date of progression or death from any cause
Measured: evaluated in 24 months since the treatment began
Secondary outcomes (4)
ORR
Baseline to measured stable disease
Measured: tumor assessment every 6 weeks since the treatment began，up to 24 months
DCR
Baseline to measured progressive disease
Measured: tumor assessment every 6 weeks since the treatment began，up to 24 months
OS
Overall survival
Measured: the first day of treatment to death or last survival confirm date,up to 24 months
Adverse events
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. The number of Participants with adverse events will be recorded at each treatment visit.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start16 Jul 2020
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian SHI, Hebei Medical University Fourth Hospital
- Investigators
- Baoen Shan, Ph.D, Principal investigator, Hebei Medical University Fourth HospitalJian Shi, Ph.D, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282278
- Sponsor's protocol ID
- HRHB-C001
- Status last verified
- Dec 2021
- First submitted
- 18 Feb 2020
- Last updated
- 10 Dec 2021
- 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 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Anti-PD-1 Antibody Multimodal Combination as First-line Treatment on Time Window of Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT04282278
- Acronym / sponsor ID
- HRHB-C001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 24 Feb 2020 (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.
The purpose of this study is to assess time window, efficacy and safety of patients who receive anti-PD-1 antibody multimodal combination as first-line treatment of advanced solid tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Camrelizumab/sintilimab+ Standard chemotherapy |
| Group B | Experimental | Drug: Camrelizumab/sintilimab+ apatinib（Intolerance to chemotherapy / refuse chemotherapy） |
| Group C | Experimental | Drug: Camrelizumab/sintilimab+ apatinib+ Standard chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age:18 to 70 years old;
- Patients with advanced solid tumors confirmed by histopathology or cytology and genetic testing was negative;
- None previous chemotherapy, Antiangiogenic targeted therapy, Immune checkpoint inhibitors therapy（NOTE: neoadjuvant and adjuvant therapy is allowed）;
- At least one measurable lesion (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Key exclusion criteria (11 listed)
- Patients with symptomatic brain metastases;
- Subjects with immunosuppressive medications within 14 days of first administration of study treatment, prednisone is used for less than 1 week, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose);
- The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, Hyperthyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
- Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ, dual or multiple primary tumors);
- Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA ≥1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study ;
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 |
|---|---|---|
| Camrelizumab/sintilimab+ Standard chemotherapyCamrelizumab/sintilimab：200mg，iv，30min，d4，q3w，24 months Standard chemotherapy：Researcher chooses standard treatment by recommended guidelines，d 1-3 | Drug | Group A |
| Camrelizumab/sintilimab+ apatinib（Intolerance to chemotherapy / refuse chemotherapy）Camrelizumab/sintilimab：200mg，iv，30min，d4，q3w，24 months Apatinib：250mg，d1，qd，po | Drug | Group B |
| Camrelizumab/sintilimab+ apatinib+ Standard chemotherapyCamrelizumab/sintilimab：200mg，iv，30min，d7，q3w，24 months Apatinib：250mg，d1，qd，po Standard chemotherapy：Researcher chooses standard treatment by recommended guidelines，d 1-3 | Drug | Group C |
Primary outcome
PFS
Time frame: evaluated in 24 months since the treatment began
Baseline to measured date of progression or death from any cause
4 secondary outcomes
ORR
Time frame: tumor assessment every 6 weeks since the treatment began，up to 24 months
DCR
Time frame: tumor assessment every 6 weeks since the treatment began，up to 24 months
OS
Time frame: the first day of treatment to death or last survival confirm date,up to 24 months
Adverse events
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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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.
Baoen Shan, Ph.D principal investigator
Hebei Medical University Fourth Hospital
Jian Shi, Ph.D principal investigator
Hebei Medical University Fourth Hospital
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/sintilimab+ Standard chemotherapy, Camrelizumab/sintilimab+ apatinib（Intolerance to chemotherapy / refuse chemotherapy） and Camrelizumab/sintilimab+ apatinib+ Standard chemotherapy in people with Advanced Solid Tumor, run by Hebei Medical University Fourth Hospital 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 8 inclusion and 11 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 10 Dec 2021. 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 Jian Shi, Ph.D (13831110729, shijian6668@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: evaluated in 24 months since the treatment began). 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 10 Dec 2021.