- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03904537
A Study of Combination of Anti-PD1 Antibody-activated TILs and Chemotherapy in Colorectal Cancer
A Phase I/II Study of Combination of Anti-Programmed Cell Death Protein 1(Anti-PD1) Antibody-activated Autologous Tumor Infiltrating Lymphocytes (TILs) and Chemotherapy in the Treatment of Stage III Colorectal Cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative colon cancer participants received 4 to 8 cycles of XELOX regimen adjuvant chemotherapy and received anti-PD1 antibody-activated TILs on the day 15 of the final cycle of chemotherapy.
Fresh tumor tissues or sentinel lymph nodes were collected from participants with postoperative colon cancer, and the tumor tissues were digested with type IV collagenase at 37 °C for 2 to 4 hours. The cell pellet was washed, suspended in medium containing 10% AB serum, planted in a 24-well cell culture plate, and periodically changed according to the growth of the cells. After culturing for 2 to 3 weeks, TILs were co-stimulated with radioactively irradiated allogeneic peripheral blood mononuclear cells (PBMCs) and were expanded in 100 ml of Interleukin-2 (IL-2) medium in a cell culture flask. After rapid expansion for 15 days, the number of cells reached 0.1-1*10^10 cells. Before cell transfer, TILs were incubated with anti-PD-1 antibody, and a fraction of the TILs were collected to assess their number, phenotype, and viability of cells, and to test for possible contamination by bacteria, fungi, or endotoxins. Then, autologous TILs (0.1-1*10^10 cells) were transferred to participants via intravenous infusion.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-sen University, Cancer Center
-
Contact:
- De-Sheng Weng, Ph.D.
- Phone Number: 86-20-87343404
- Email: wengds@sysucc.org.cn
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Principal Investigator:
- De-Sheng Weng, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants with stage III colorectal cancer and scheduled to receive adjuvant chemotherapy postoperation.
- Age 18 to 75 years.
- Willing to sign a durable power of attorney.
- Able to understand and sign the Informed Consent Document.
- Life expectancy of greater than six months.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the preparative regimen.
- Adequate organ function.
- Serology:
Seronegative for HIV antibody. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
•Hematology: white blood cell count (> 3500/mm(3)). Platelet count greater than 100,000/mm(3). Hemoglobin greater than 9.0 g/dl.
•Chemistry: Serum Alanine aminotransferase/Aspartate aminotransferase less or equal to 2.5 times the upper limit of normal.
Serum creatinine less than or equal to 1.6 mg/dl. Total bilirubin less than or equal to 1.5 mg/dl.
Exclusion Criteria:
- Previous treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) , anti-PD-1, and anti-Programmed death-ligand 1(PD-L1).
- Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
- Allogeneic tissue/organ transplantation.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- History of autoimmune disease
- Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
- Concurrent antineoplastic therapies and systemic steroid therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PD1-TIL combined with chemotherapy
Participants would received anti-PD-1 antibody-activated TILs after the final adjuvant chemotherapy.
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Participants would received one dose anti-PD-1 antibody-activated TILs at the final cycle of XELOX regimen chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-free survival (DFS)
Time Frame: 6 months
|
DFS is defined as the time from surgery until tumor recurrence or death.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The quality of life by EQ-5D-5L (EuroQol Group, Chinese versions )
Time Frame: 3 weeks
|
Participants were interviewed with the EQ-5D-5L (EuroQol Group, Chinese versions).
There are numbers from 0 to 100 on this scale of the EQ-5D-5L.
100 represents the best health condition you can imagine, and 0 represents the worst health condition in your imagination.
Please put an X on the scale to indicate how healthy you are today.
And the number you marked on the scale represents your health condition today.
|
3 weeks
|
Overall survival (OS)
Time Frame: 6 months
|
OS is defined as the time from surgery until death from any cause
|
6 months
|
Severity of adverse events
Time Frame: 3 weeks
|
According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE)
|
3 weeks
|
Immune cell subgroup and cytokine level
Time Frame: 1 months
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The number and secreted cytokines of cluster of differentiation 3 (CD3+), CD8+, CD4+ or CD56+ T cells
|
1 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2018-148-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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