Colorectal Cancer Stage III Clinical Trial
Official title:
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.
Verified date | April 2019 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was a phase I/II trial initiated by the investigator to evaluate the safety and tolerability of anti-programmed cell death protein 1 (anti-PD1) antibody-activated autologous tumor-infiltrating lymphocytes (TILs) combined with adjuvant chemotherapy in participants with stage III colon cancer. Twenty participants were enrolled and anti-PD1 antibody-activated TILs was infused into participants after the final of adjuvant chemotherapy to assess the safety and 3-year disease-free survival.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-Sen University, Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-free survival (DFS) | DFS is defined as the time from surgery until tumor recurrence or death. | 6 months | |
Secondary | Overall survival (OS) | OS is defined as the time from surgery until death from any cause | 6 months | |
Secondary | Severity of adverse events | According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE) | 3 weeks | |
Secondary | Immune cell subgroup and cytokine level | The number and secreted cytokines of cluster of differentiation 3 (CD3+), CD8+, CD4+ or CD56+ T cells | 1 months | |
Secondary | The quality of life by EQ-5D-5L (EuroQol Group, Chinese versions ) | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01570452 -
Matrilysin Expression in Different Stages of Colorectal Tumors
|
N/A | |
Active, not recruiting |
NCT04304209 -
Pd1 Antibody Sintilimab ± Chemoradiotherapy for Locally Advanced Rectal Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04398446 -
Effect of Hemp-CBD on Patients With CIPN
|
Phase 2 | |
Recruiting |
NCT04486378 -
A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT04264676 -
Study of Oral Metronidazole on Postoperative Chemotherapy in Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06314958 -
Stage II/III Colorectal Cancer Recurrence
|
||
Recruiting |
NCT06342440 -
Early Detection of Advanced Adenomas and Colorectal Cancer
|
||
Recruiting |
NCT04714814 -
Mechanisms of Fate Evolution of Colorectal Adenocarcinoma Metastasis
|
||
Recruiting |
NCT05898789 -
Virtual Rehabilitation for Cancer Survivors
|
N/A | |
Completed |
NCT01356264 -
Multimodal Prehabilitation for Colorectal Surgery
|
Phase 2 | |
Recruiting |
NCT04813627 -
Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy
|
||
Recruiting |
NCT03448549 -
SOX Versus XELOX as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients
|
Phase 3 | |
Not yet recruiting |
NCT05131243 -
the Role of ctDNA in Predicting the Recurrence Risk of Colorectal Cancer
|
N/A | |
Recruiting |
NCT06076811 -
DANISH.MRD: Danish Assessment of Minimal Residual Disease by Liquid Biopsies
|
||
Recruiting |
NCT06111105 -
Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Colorectal Cancer
|
||
Recruiting |
NCT06342401 -
Early Onset Colorectal Cancer Detection
|
||
Completed |
NCT06271980 -
Early-Onset Colorectal Cancer Recurrence
|