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To investigate the safety of MASCT-1 on patients with colorectal cancer who underwent adjuvant chemotherapy after radical mastectomy.

To investigate the safety of MASCT-1 on patients with colorectal cancer who underwent adjuvant chemotherapy after radical mastectomy.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-17013136
Enrollment
Unknown
Registered
2017-10-28
Start date
2017-12-01
Completion date
Unknown
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer (stage II and III)

Interventions

Intervention group:MASCT-I

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-70 years old at screening stage; 2. Obtain written informed consent of the patient / legal representative before proceeding with any program-related procedures, including the assessment of the screening period; 3. The American Eastern Cooperative Association (ECOG) physical status score was 0-1 points; 4. Life expectancy =12 months; 5. Cardiopulmonary function is normal; 6. (peripheral blood) cells proliferate well. 7. After radical surgery (including neoadjuvant therapy after surgery) and receive adjuvant chemotherapy of ?, ? patients with colorectal cancer; 8. Histopathological examination for well differentiated or poorly differentiated adenocarcinoma; 9. at least 1 month after the end of chemotherapy can be screened.;Inclusion criteria: 1. aged 18-70 years old at screening stage; 2. Obtain written informed consent of the patient / legal representative before proceeding with any program-related procedures, including the assessment of the screening period; 3. The American Eastern Cooperative Association (ECOG) physical status score was 0-1 points; 4. Life expectancy =12 months; 5. Cardiopulmonary function is normal; 6. (peripheral blood) cells proliferate well. 7. After radical surgery (including neoadjuvant therapy after surgery) and receive adjuvant chemotherapy of ?, ? patients with colorectal cancer; 8. Histopathological examination for well differentiated or poorly differentiated adenocarcinoma; 9. at least 1 month after the end of chemotherapy can be screened.;Inclusion criteria: 1. aged 18-70 years old at screening stage; 2. Obtain written informed consent of the patient / legal representative before proceeding with any program-related procedures, including the assessment of the screening period; 3. The American Eastern Cooperative Association (ECOG) physical status score was 0-1 points; 4. Life expectancy =12 months; 5. Cardiopulmonary function is normal; 6. (peripheral blood) cells proliferate well. 7. After radical surgery (including neoadjuvant therapy after surgery) and receive adjuvant chemotherapy of ?, ? patients with colorectal cancer; 8. Histopathological examination for well differentiated or poorly differentiated adenocarcinoma; 9. at least 1 month after the end of chemotherapy can be screened.;Inclusion criteria: 1. aged 18-70 years old at screening stage; 2. Obtain written informed consent of the patient / legal representative before proceeding with any program-related procedures, including the assessment of the screening period; 3. The American Eastern Cooperative Association (ECOG) physical status score was 0-1 points; 4. Life expectancy =12 months; 5. Cardiopulmonary function is normal; 6. (peripheral blood) cells proliferate well. 7. After radical surgery (including neoadjuvant therapy after surgery) and receive adjuvant chemotherapy of ?, ? patients with colorectal cancer; 8. Histopathological examination for well differentiated or poorly differentiated adenocarcinoma; 9. at least 1 month after the end of chemotherapy can be screened.;Inclusion criteria: 1. aged 18-70 years old at screening stage; 2. Obtain written informed consent of the patient / legal representative before proceeding with any program-related procedures, including the assessment of the screening period; 3. The American Eastern Cooperative Association (ECOG) physical status score was 0-1 points; 4. Life expectancy =12 months; 5. Cardiopulmonary function is normal; 6. (peripheral blood) cells proliferate well. 7. After radical surgery (including neoadjuvant therapy after surgery) and receive adjuvant chemotherapy of ?, ? patients with colorectal cancer; 8. Histopathological examination for well differentiated or poorly differentiated adenocarcinoma; 9. at least 1 month after the end of chemotherapy can be screened.

Exclusion criteria

Exclusion criteria: 1. There are liver, lungs or other distant metastases; 2. local late or local can not be removed or clinically intolerable; 3. Subjects are using immunosuppressive agents, or systemic, or absorbable topical hormones for immunosuppressive purposes (doses> 10 mg / day of prednisone or other therapeutic hormones) and within 2 weeks prior to enrollment Still in use; 4. systemic or long-term use of immune modulators such as interferon, thymosin and immunosuppressive drugs such as adrenal cortex hormones; systemic or long-term use refers to the immune regulator continuous standard medication for more than 3 months , Immunosuppressive drugs continuous standardized medication for more than 1 month; 5. Subjects had previously received MASCT or other cellular immunotherapy; 6. Subjects have any active autoimmune disease or history of autoimmune diseases; 7. Subjects have active tuberculosis; hepatitis B, hepatitis C or HIV infection, or syphilis infection; 8. The researchers have determined that other factors may lead to intermediate termination, such as other serious diseases (including mental illness) need to merge treatment, there are serious laboratory abnormalities, accompanied by family or social factors, will Affect the safety of the subject, or the collection of test data and samples.;Exclusion criteria: 1. There are liver, lungs or other distant metastases; 2. local late or local can not be removed or clinically intolerable; 3. Subjects are using immunosuppressive agents, or systemic, or absorbable topical hormones for immunosuppressive purposes (doses> 10 mg / day of prednisone or other therapeutic hormones) and within 2 weeks prior to enrollment Still in use; 4. systemic or long-term use of immune modulators such as interferon, thymosin and immunosuppressive drugs such as adrenal cortex hormones; systemic or long-term use refers to the immune regulator continuous standard medication for more than 3 months , Immunosuppressive drugs continuous standardized medication for more than 1 month; 5. Subjects had previously received MASCT or other cellular immunotherapy; 6. Subjects have any active autoimmune disease or history of autoimmune diseases; 7. Subjects have active tuberculosis; hepatitis B, hepatitis C or HIV infection, or syphilis infection; 8. The researchers have determined that other factors may lead to intermediate termination, such as other serious diseases (including mental illness) need to merge treatment, there are serious laboratory abnormalities, accompanied by family or social factors, will Affect the safety of the subject, or the collection of test data and samples.;Exclusion criteria: 1. There are liver, lungs or other distant metastases; 2. local late or local can not be removed or clinically intolerable; 3. Subjects are using immunosuppressive agents, or systemic, or absorbable topical hormones for immunosuppressive purposes (doses> 10 mg / day of prednisone or other therapeutic hormones) and within 2 weeks prior to enrollment Still in use; 4. systemic or long-term use of immune modulators such as interferon, thymosin and immunosuppressive drugs such as adrenal cortex hormones; systemic or long-term use refers to the immune regulator continuous standard medication for more than 3 months , Immunosuppressive drugs continuous standardized medication for more than 1 month; 5. Subjects had previously received MASCT or other cellular immunotherapy; 6. Subjects have any active autoimmune disease or history of autoimmune diseases; 7. Subjects have active tuberculosis; hepatitis B, hepatitis C or HIV infection, or syphilis infection; 8. The researchers have determined that other factors may lead to intermediate termination, such as other serious diseases (including mental illness) need to merge treatment, there are serious laboratory abnormalities, accompanied by family or social factors, will Affect the safety of the subject, or the collection of test data and samples.;Exclusion criteria: 1. There are liver, lungs or other distant metastases; 2. local late or local can not be removed or clinically intolerable; 3. Subjects are using immunosuppressive agents, or systemic, or absorbable topical hormones for immunosuppressive purposes (doses> 10 mg / day of prednisone or other therapeutic hormones) and within 2 weeks prior to enrollment Still in use; 4. systemic or long-term use of immune modulators such as interferon, thymosin and immunosuppressive drugs such as adrenal cortex hormones; systemic or long-term use refers to the immune regulator continuous standard medication for more than 3 months , Immunosuppressive drugs continuous standardized medication for more than 1 month; 5. Subjects had previously received MASCT or other cellular immunotherapy; 6. Subjects have any active autoimmune disease or history of autoimmune diseases; 7. Subjects have active tuberculosis; hepatitis B, hepatitis C or HIV infection, or syphilis infection; 8. The researchers have determined that other factors may lead to intermediate termination, such as other serious diseases (including mental illness) need to merge treatment, there are serious laboratory abnormalities, accompanied by family or social factors, will Affect the safety of the subject, or the collection of test data and samples.;Exclusion criteria: 1. There are liver, lungs or other distant metastases; 2. local late or local can not be removed or clinically intolerable; 3. Subjects are using immunosuppressive agents, or systemic, or absorbable topical hormones for immunosuppressive purposes (doses> 10 mg / day of prednisone or other therapeutic hormones) and within 2 weeks prior to enrollment Still in use; 4. systemic or long-term use of immune modulators such as interferon, thymosin and immunosuppressive drugs such as adrenal cortex hormones; systemic or long-term use refers to the immune regulator continuous standard medication for more than 3 months , Immunosuppressive drugs continuous standardized medication for more than 1 month; 5. Subjects had previously received MASCT or other cellular immunotherapy; 6. Subjects have any active autoimmune disease or history of autoimmune diseases; 7. Subjects have active tuberculosis; hepatitis B, hepatitis C or HIV infection, or syphilis infection; 8. The researchers have determined that other factors may lead to intermediate termination, such as other serious diseases (including mental illness) need to merge treatment, there are serious laboratory abnormalities, accompanied by family or social factors, will Affect the safety of the subject, or the collection of test data and samples.

Design outcomes

Primary

MeasureTime frame
PFS;OS;

Countries

China

Contacts

Public ContactZeqiang Zhou;Zeqiang Zhou;Zeqiang Zhou;Zeqiang Zhou;Zeqiang Zhou ;;;;

Department of Oncology, Shenzhen Second People's Hospital;Department of Oncology, Shenzhen Second People's Hospital;Department of Oncology, Shenzhen Second People's Hospital;Department of Oncology, Shenzhen Second People's Hospital;Department of Oncology, Shenzhen Second People's Hospital

szchou123@163.com;szchou123@163.com;szchou123@163.com;szchou123@163.com;szchou123@163.com+86 13600166286;+86 13600166286;+86 13600166286;+86 13600166286;+86 13600166286

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026