NCT03904537

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

March 31, 2019

Last Update Submit

April 3, 2019

Conditions

Colorectal Cancer Stage III

Keywords

Colorectal CancerTILimmunotherapy

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival (DFS）

    DFS is defined as the time from surgery until tumor recurrence or death.

    6 months

Secondary Outcomes (4)

  • Overall survival (OS)

    6 months

  • Severity of adverse events

    3 weeks

  • Immune cell subgroup and cytokine level

    1 months

  • The quality of life by EQ-5D-5L (EuroQol Group, Chinese versions )

    3 weeks

Study Arms (1)

PD1-TIL combined with chemotherapy

EXPERIMENTAL

Participants would received anti-PD-1 antibody-activated TILs after the final adjuvant chemotherapy.

Biological: anti-PD-1 antibody-activated TILs

Interventions

anti-PD-1 antibody-activated TILsBIOLOGICAL

Participants would received one dose anti-PD-1 antibody-activated TILs at the final cycle of XELOX regimen chemotherapy

PD1-TIL combined with chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen University, Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Biotherapy

Study Record Dates

First Submitted

March 31, 2019

First Posted

April 5, 2019

Study Start

February 19, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2021

Last Updated

April 5, 2019

Record last verified: 2019-04

Locations

CN(1)