Evaluation of safty of personalized Colon Cancer Cell Vaccine

Evaluation of safty of an indigenous Autologous Colon Cancer Cell Vaccine-immunotherapy combined with chemotherapy in stage 4 colorectal cancer patients

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210620051632N1

Enrollment

Registered

2022-01-12

Start date

2022-04-04

Completion date

Unknown

Last updated

2022-02-07

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

Conditions

Colorectal Cancer. Malignant neoplasm of colon, Malignant neoplasm of rectosigmoid junction, Malignant neoplasm of rectum, Malignant neoplasm of anus and anal canal,

Interventions

Intervention 1: Intervention group: Patients with colorectal cancer, stage 4 which receive chemotherapy and vaccine. Autologous vaccine will be injected in two periods. The first period consists of

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Colorectal cancer, stage 4

Exclusion criteria

Exclusion criteria: History of any previous malignancy History of radiation therapy or chemotherapy History of more than one malignant colon cancer.

Design outcomes

Primary

Measure	Time frame
Investigation of tumor markers levels (CEA, CA19-9) and liver enzymes and no new tumor formation. Timepoint: 6 months after the last vaccination. Method of measurement: Measure the umor markers levels (CEA, CA19-9) and liver enzymes concentration via Elisa method, and assay the new tumor formation via colonoscopy.	—

Secondary

Measure	Time frame
Overall survival and Score of quality of life; Gastrointestinal, renal, hepatic, cardiac, respiratory, neurological, skin, musculoskeletal, joint and allergic adverse effects. Timepoint: Overall survival will be assay 2 years after vaccination. Score of quality of life will be assay after third and sixth vaccinations and also 6 and 12 months after sixth vaccination. Gastrointestinal, renal, hepatic, cardiac, respiratory, neurological, skin, musculoskeletal, joint and allergic adverse effects, will be assay 12 and 48 hours, 2 week and 6 month after sixth vaccination. Method of measurement: Overall survival will be detected by Lifespan after vaccination. Quality of life will be detected via quality of life questionnaire. adverse effects of vaccine will be detected by physician.	—

Measure

Time frame

Overall survival and Score of quality of life; Gastrointestinal, renal, hepatic, cardiac, respiratory, neurological, skin, musculoskeletal, joint and allergic adverse effects. Timepoint: Overall survival will be assay 2 years after vaccination. Score of quality of life will be assay after third and sixth vaccinations and also 6 and 12 months after sixth vaccination. Gastrointestinal, renal, hepatic, cardiac, respiratory, neurological, skin, musculoskeletal, joint and allergic adverse effects, will be assay 12 and 48 hours, 2 week and 6 month after sixth vaccination. Method of measurement: Overall survival will be detected by Lifespan after vaccination. Quality of life will be detected via quality of life questionnaire. adverse effects of vaccine will be detected by physician.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hassan Emami

Poursina Hakim Digestive Diseases Research Center

mh_emami@med.mui.ac.ir+98 31 3554 8151

Outcome results

None listed

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