Colorectal CancerPhase 3NCT03950154
Study of Chemotherapy Combination With Autologous Cell Immunotherapy in the Recurrent and Metastatic Colorectal Cancer
A Phase 3 study testing Bevacizumab Injection [Avastin], Oxaliplatin and Capecitabine in people with Colorectal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study evaluates the effect and safty of PD-1 monoclonal antibody-activated autologous peripheral blood lymphocyte (PD1-T) combined with XELOX and bevacizumab in the first-line treatment of recurrent and metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Bevacizumab Injection [Avastin], Oxaliplatin and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Aug 2023
- Phase
- Phase 3
- 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
- Subjects who must meet all the following criteria should be selected:
- Agreeing to participate in this study and signing a written informed consent.
- Male or female,from 18 to 75 years (including 18 and 75 years).
- The life expectancy is longer than 3 months and can be followed up.
- Patients with metastatic colorectal cancer whose condition has progressed after operation or could not receive radical surgery at initial treatment, will be confirmed by histological /cytological and imaging examinations. According to RECIST 1.1 standard, there will be at least one measurable lesion.
- Bevacizumab, oxaliplatin and capecitabine were not used at least 6 months before the first administration of the drug in the patients with metastatic colorectal cancer whose condition has progressed after operation.
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- ECOG score will be 0 or 1 within 7 days before randomization.
- Within 14 days before the start of treatment, the results of laboratory test of blood routine, liver, kidney function and hormone levels must be met the following criteria:
- White blood cells: more than 3.0 × 109/L; Platelets: more than 100 × 109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 80g/L; Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN); Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN; Serum bilirubin: less than 1.25 × ULN; Serum creatinine: less than 1.25 × ULN. Cortisol and thyroid function will be in the normal range.
- The toxicity and side effects of previous chemotherapy will must be alleviated to grade 1 or below (except hair loss).If the subjects received major surgical treatment or radiotherapy of > 30 Gy, they must recover from the toxicity or complications of these interventions, that is, they can be enrolled after 6 months.
- Female subjects must take effective contraceptive measures throughout the study period; serum or urine pregnancy test results must be negative during screening and the whole study period.
- Male subjects should take effective contraceptive measures from the beginning of treatment to within 6 months after the end of treatment.
Who cannot join
- Subjects who meet any of the following criteria could not participate in this study:
- Bevacizumab or oxaliplatin or capecitabine were used within 6 months before the first use of the study drug.
- Patients received major surgery or local radiotherapy of more than 30 Gy within six months before the first use of the drug; received local radiofrequency, ablation, cryotherapy or radiotherapy of 30 Gy or less within one month before the first use of the drug; or received anti-tumor monoclonal antibody (mAb), chemotherapy and targeted small molecule therapy within one month before the first use of the drug. Patients with metastases who can undergo radical surgery.
- Other malignant tumors needed treatment within five years.
- Allogeneic tissue/organ transplantation.
- Participating in research drug therapy within 4 weeks before the first administration of the trial.
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- Systemic glucocorticoid therapy or any other form of immunosuppressive therapy (except glucocorticoid preconditioned with docetaxel) is being administered within 3 days before the first administration of the experimental therapy.
- Previous treatment with PD-1/PD-L1 antibodies.
- Over the past two years, patients with active autoimmune diseases requiring systemic treatment, such as the use of corticosteroids, or immunosuppressants. Substitution therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) is not a systemic treatment.
- Having bleeding tendency, high risk of bleeding or coagulation dysfunction, having a history of thrombosis within 6 months and/or hemoptysis within 3 months; being treated with full oral and/or parenteral anticoagulants and thrombolysis agents (preventive use of anticoagulants is permitted); having used aspirin or other non-steroidal anti-inflammatory drugs that inhibit platelet function within 10 days; / MR imaging showed that the tumors surrounded or invaded the large vessel lumen.
- Patients with congenital or acquired immunodeficiency (e.g. HIV-infected persons), active hepatitis B (HBV-DNA > 10^3 copies/ml) or hepatitis C (hepatitis C antibody positive), and HCV-RNA higher than the detection limit of the analytical method.
- Poorly controlled hypertension (systolic pressure 150 mmHg and/or diastolic pressure 100 mmHg), previous hypertension crisis and hypertensive encephalopathy, and severe cerebrovascular diseases.
- Non-healing wounds, active peptic ulcer, tracheoesophageal fistula, gastrointestinal perforation and abdominal abscess within 6 months.
- Subjects with active central nervous system (CNS) metastases and/or cancerous meningitis.
- Patients with active infections requiring systemic intravenous therapy.
- Mental illness or other illnesses, such as uncontrollable heart disease or pulmonary disease, diabetes, etc.
- Subjects who are known to be allergic to any of the constituents of the drug being studied.
- Subjects with a recent history of drug abuse (including alcohol) within one year.
- Compliance is poor and can not cooperate with clinical research.
- Female subjects who are pregnant or breastfeeding, or who are expected to be pregnant during the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Liang Liu, MD., 86-22-23340123 ext. 3172, liangcoh@163.com
Xiubao Ren, MD. PhD., 86-22-23340123 ext. 3173, renxiubao@tjmuch.com
About this study
Official title: Phase III Clinical Study of PD-1 Monoclonal Antibody-activated Autologous Peripheral Blood T-lymphocyte (PD1-T) Combined With XELOX and Bevacizumab in the First-line Treatment of Recurrent and Metastatic Colorectal Cancer
This study evaluates the effect and safty of PD-1 monoclonal antibody-activated autologous peripheral blood lymphocyte (PD1-T) combined with XELOX and bevacizumab in the first-line treatment of recurrent and metastatic colorectal cancer. Half of participants receive PD1-T combined with XELOX and bevacizumab, while the other half will receive XELOX and bevacizumab.
- Conditions
- Colorectal Cancer
- Being tested
- Bevacizumab Injection [Avastin], Oxaliplatin, Capecitabine, PD1-T cells
- Keywords
- effcet, safety
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab Injection [Avastin]Drug
Also called Avastin
Bevacizumab injection
OxaliplatinDrug
Oxaliplatin injection
CapecitabineDrug
Capecitabine oral agent
PD1-T cellsBiological
Also called PD-1 monoclonal antibody-activated peripheral blood T-lymphocyte
PD1-T cells injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Bevacizumab \& Oxaliplatin \& Capecitabine \& PD1-T cells
Bevacizumab, 7.5mg/kg, intravenous infusion, d1; Oxaliplatin, 130mg/m2, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; PD1-T cells, 1x10^10 (10 billion), intravenous infusion, d17; Q3W, 6 cycles. After 6 cycles, Bevacizumab, 7.5mg/kg, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; Q3W, maintenance treatment. Receives: Drug: Bevacizumab Injection [Avastin]; Drug: Oxaliplatin; Drug: Capecitabine; Biological: PD1-T cells |
| Arm 2: Control | Active comparator | Bevacizumab \& Oxaliplatin \& Capecitabine
Bevacizumab, 7.5mg/kg, intravenous infusion, d1; Oxaliplatin, 130mg/m2, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; Q3W, 6 cycles. After 6 cycles, Bevacizumab, 7.5mg/kg, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; Q3W, maintenance treatment. Receives: Drug: Bevacizumab Injection [Avastin]; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
PFS will be calculated from initiation of treat- ment until first progression, and patients alive in stable state will be censored at the time of last contact.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jun 2019
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiubao Ren, MD. PhD., Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950154
- Sponsor's protocol ID
- B2019-023-01
- Status last verified
- Jul 2023
- First submitted
- 28 Apr 2019
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pan QZ, Zhao JJ, Liu L, Zhang DS, Wang LP, Hu WW, Weng DS, Xu X, Li YZ, Tang Y, Zhang WH, Li JY, Zheng X, Wang QJ, Li YQ, Xiang T, Zhou L, Yang SN, Wu C, Huang RX, He J, Du WJ, Chen LJ, Wu YN, Xu B, Shen Q, Zhang Y, Jiang JT, Ren XB, Xia JC. XELOX (capecitabine plus oxaliplatin) plus bevacizumab (anti-VEGF-A antibody) with or without adoptive cell immunotherapy in the treatment of patients with previously untreated metastatic colorectal cancer: a multicenter, open-label, randomized, controlled, phase 3 trial. Signal Transduct Target Ther. 2024 Apr 3;9(1):79. doi: 10.1038/s41392-024-01788-2.
PubMed 38565886
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Study of PD-1 Monoclonal Antibody-activated Autologous Peripheral Blood T-lymphocyte (PD1-T) Combined With XELOX and Bevacizumab in the First-line Treatment of Recurrent and Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03950154
- Acronym / sponsor ID
- B2019-023-01
- Conditions
- Colorectal Cancer
- Keywords
- effcet, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 15 May 2019 (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 evaluates the effect and safty of PD-1 monoclonal antibody-activated autologous peripheral blood lymphocyte (PD1-T) combined with XELOX and bevacizumab in the first-line treatment of recurrent and metastatic colorectal cancer. Half of participants receive PD1-T combined with XELOX and bevacizumab, while the other half will receive XELOX and bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Bevacizumab Injection [Avastin], Drug: Oxaliplatin, Drug: Capecitabine, Biological: PD1-T cellsBevacizumab \& Oxaliplatin \& Capecitabine \& PD1-T cells Bevacizumab, 7.5mg/kg, intravenous infusion, d1; Oxaliplatin, 130mg/m2, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; PD1-T cells, 1x10^10 (10 billion), intravenous infusion, d17; Q3W, 6 cycles. After 6 cycles, Bevacizumab, 7.5mg/kg, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; Q3W, maintenance treatment. |
| Arm 2: Control | Active comparator | Drug: Bevacizumab Injection [Avastin], Drug: Oxaliplatin, Drug: CapecitabineBevacizumab \& Oxaliplatin \& Capecitabine Bevacizumab, 7.5mg/kg, intravenous infusion, d1; Oxaliplatin, 130mg/m2, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; Q3W, 6 cycles. After 6 cycles, Bevacizumab, 7.5mg/kg, intravenous infusion, d1; Capecitabine, 1g/m2, oral administration, d1-14; Q3W, maintenance treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Agreeing to participate in this study and signing a written informed consent.
- Male or female,from 18 to 75 years (including 18 and 75 years).
- The life expectancy is longer than 3 months and can be followed up.
- Patients with metastatic colorectal cancer whose condition has progressed after operation or could not receive radical surgery at initial treatment, will be confirmed by histological /cytological and imaging examinations. According to RECIST 1.1 standard, there will be at least one measurable lesion.
- Bevacizumab, oxaliplatin and capecitabine were not used at least 6 months before the first administration of the drug in the patients with metastatic colorectal cancer whose condition has progressed after operation.
Key exclusion criteria (20 listed)
- Bevacizumab or oxaliplatin or capecitabine were used within 6 months before the first use of the study drug.
- Patients received major surgery or local radiotherapy of more than 30 Gy within six months before the first use of the drug; received local radiofrequency, ablation, cryotherapy or radiotherapy of 30 Gy or less within one month before the first use of the drug; or received anti-tumor monoclonal antibody (mAb), chemotherapy and targeted small molecule therapy within one month before the first use of the drug. Patients with metastases who can undergo radical surgery.
- Other malignant tumors needed treatment within five years.
- Allogeneic tissue/organ transplantation.
- Participating in research drug therapy within 4 weeks before the first administration of the trial.
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 |
|---|---|---|
| Bevacizumab Injection [Avastin]Also: AvastinBevacizumab injection | Drug | Arm 1, Arm 2: Control |
| OxaliplatinOxaliplatin injection | Drug | Arm 1, Arm 2: Control |
| CapecitabineCapecitabine oral agent | Drug | Arm 1, Arm 2: Control |
| PD1-T cellsAlso: PD-1 monoclonal antibody-activated peripheral blood T-lymphocytePD1-T cells injection | Biological | Arm 1 |
Primary outcome
Progression-free survival
Time frame: 3 years
PFS will be calculated from initiation of treat- ment until first progression, and patients alive in stable state will be censored at the time of last contact.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Derived from this study: PubMed 38565886Pan QZ, Zhao JJ, Liu L, Zhang DS, Wang LP, Hu WW, Weng DS, Xu X, Li YZ, Tang Y, Zhang WH, Li JY, Zheng X, Wang QJ, Li YQ, Xiang T, Zhou L, Yang SN, Wu C, Huang RX, He J, Du WJ, Chen LJ, Wu YN, Xu B, Shen Q, Zhang Y, Jiang JT, Ren XB, Xia JC. XELOX (capecitabine plus oxaliplatin) plus bevacizumab (anti-VEGF-A antibody) with or without adoptive cell immunotherapy in the treatment of patients with previously untreated metastatic colorectal cancer: a multicenter, open-label, randomized, controlled, phase 3 trial. Signal Transduct Target Ther. 2024 Apr 3;9(1):79. doi: 10.1038/s41392-024-01788-2.
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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.
Xiubao Ren, MD. PhD. study chair
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevacizumab Injection [Avastin], Oxaliplatin and Capecitabine in people with Colorectal Cancer, run by Tianjin Medical University Cancer Institute and 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 12 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 1 Aug 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xiubao Ren, MD. PhD. (86-22-23340123 ext. 3173, liangcoh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03950154, which also lists 1 linked publication.
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 1 Aug 2023.