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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab Injection [Avastin] | Drug | Bevacizumab injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
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Inclusion Criteria:
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.
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.
Exclusion Criteria:
Subjects who meet any of the following criteria could not participate in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiubao Ren, MD. PhD. | Contact | 86-22-23340123 | 3173 | liangcoh@163.com |
| Liang Liu, MD. | Contact | 86-22-23340123 | 3172 | renxiubao@tjmuch.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiubao Ren, MD. PhD. | Tianjin Medical University Cancer Institute and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38565886 | Derived | 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. |
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| Oxaliplatin | Drug | Oxaliplatin injection |
|
| Capecitabine | Drug | Capecitabine oral agent |
|
| PD1-T cells | Biological | PD1-T cells injection |
|
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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