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Trial Title:
Genotype-driven Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer
NCT ID:
NCT06300489
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Capecitabine
Irinotecan
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
irinotecan liposomes+capecitabine
Description:
Radiotherapy:IMRT DT 50Gy/25Fx. Capecitabine: 625mg/m2 bid po d1-5 qw. For patients are
double sites mutant (GG+7/7 or AA+6/6 or GA+6/7),the intial dose of Irinotecan liposomes
is 25mg/m2 weekly,for four weeks。 This study stratify cases by the "3+3" rule according
to UGT1A1 * 6 and UGT1A1 * 28 phenotypes. Three cases were enrolled in each dose group,
and if there was no DLT, they were promoted to the next dose group(an increase of
5mg/m2); If there is 1 case of DLT, 3 cases will be reenrolled in the same dose group. If
there is no new occurrence of DLT, it will be promoted to the next dose group. Otherwise,
the study will be terminated; If there are 2 cases of DLT, the study will be terminated,
and the previous dose group will be the maximum tolerated dose (MTD).
Arm group label:
irinotecan liposomes+capecitabine+chemoradiotherapy
Other name:
chemoradiotherapy
Summary:
This study is a multicenter, open, and phase I dose increasing clinical study. Based on
the UGT1A1 * 28 and * 6 genotypes of patients with locally advanced rectal cancer,
determine the dose limiting toxicity (DLT) and maximum tolerable dose (MTD) of weekly
irinotecan liposomes in concurrent chemoradiotherapy with capecitabine, investigate the
tolerance of irinotecan liposome combined with capecitabine in concurrent
chemoradiotherapy with locally advanced rectal cancer, and recommend the dosage for Phase
II clinical study,and explore the pharmacokinetic characteristics of irinotecan liposomes
combined with capecitabine.At the same time,Preliminary observe the efficacy and safety
of irinotecan liposomes combined with capecitabine in chemoradiotherapy.The study plans
to recruit 30 patients with advanced rectal cancer who have not received any therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Diagnosed as rectal adenocarcinoma by histopathology, immunohistochemical pMMR or
MSI-L, MSS;
2. The baseline clinical stage is T2-4 and/or N+, which is not suitable for initial
local resection to achieve curative effect;
3. The distance between the tumor and the anus is<=10cm;
4. No distant metastasis;
5. Age range from 18 to 70 years old, regardless of gender;
6. ECOG PS score 0-1 points;
7. The UGT1A1 * 6 and UGT1A1 * 28 gene phenotypes are all wild-type (GG+6/6), unit
point mutant (GG+6/7 or GA+6/6), and dual site mutant (GG+7/7 or AA+6/6 or GA+6/7);
8. Not receiving chemotherapy or any other anti-tumor treatment before enrollment;
9. Able to comply with the protocol during the research period;
10. Sign written informed consent.
Exclusion Criteria:
1. Diagnosed as rectal adenocarcinoma by pathological histology, and
immunohistochemical dMMR or MSI-H;
2. UGT1A1 * 6, UGT1A1 * 28 gene phenotype three site mutations (AA+7/7 or AA+6/7 or
GA+7/7);
3. Pregnant or lactating women
4. Individuals with a history of other malignant diseases in the past 5 years,
excluding cured skin cancer and cervical cancer in situ
5. Individuals with a history of uncontrolled epilepsy, central nervous system disease,
or mental disorders, whose clinical severity may be assessed by the researcher as
hindering the signing of informed consent forms or affecting the patient's adherence
to oral medication
6. Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart
disease, NYHA grade II or more severe congestive heart failure, or severe arrhythmia
requiring medication intervention (see Appendix 12), or a history of myocardial
infarction within the past 12 months
7. Organ transplantation requires immunosuppressive therapy
8. Severe uncontrolled recurrent infections or other serious uncontrolled comorbidities
9. The baseline blood routine and biochemical indicators of the subjects do not meet
the following criteria: hemoglobin ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5 ×
109/L; Platelets ≥ 100 × 109/L; ALT and AST ≤ 2.5 times the normal upper limit
value; ALP ≤ 2.5 times the normal upper limit value; Serum total bilirubin<1.5 times
the upper normal limit value; Serum creatinine<1 times the upper normal limit value;
Serum albumin ≥ 30g/L
10. Known individuals with dihydropyrimidine dehydrogenase (DPD) deficiency
11. Individuals who are allergic to any research medication
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Ji Zhu
Phone:
0571-88128152
Email:
leo.zhu@126.com
Start date:
March 3, 2024
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06300489