Trial Title:
SCRT Followed by Camrelizumab Combined With Fluzoparib and Chemotherapy as Neoadjuvant Therapy for LARC
NCT ID:
NCT06516445
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Fluzoparib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
SCRT
Description:
5×5Gy，5Gy/d，QD，D1-D5
Arm group label:
SCRT followed by camrelizumab combined with fluzoparib and chemotherapy
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
200mg, D1, ivgtt, Q3W, C1-4
Arm group label:
SCRT followed by camrelizumab combined with fluzoparib and chemotherapy
Intervention type:
Drug
Intervention name:
Fluzoparib
Description:
100mg, BID, PO, Q3W, C1-4
Arm group label:
SCRT followed by camrelizumab combined with fluzoparib and chemotherapy
Intervention type:
Drug
Intervention name:
CAPEOX
Description:
Capecitabine: 1000 mg/m2, BID, PO，D1-14, Q3W, C1-C4； Oxaliplatin: 130mg/m2, D1, ivgtt,
0-2h，Q3W，C1-4
Arm group label:
SCRT followed by camrelizumab combined with fluzoparib and chemotherapy
Summary:
To explore the safety and efficacy of neoadjuvant therapy for locally advanced rectal
cancer with short course radiotherapy followed by camrelizumab combined with fluzoparib
and chemotherapy
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients who provided written informed consent form for participation in this study;
2. Aged 18-75 years old, male or female;
3. Histologically confirmed pathological diagnosis of proficient mismatch
repair/microsatellite stable(pMMR/MSS) rectal adenocarcinoma;
4. The lower margin of the tumor is ≤10cm from the anal verge;
5. Clinical Stage (according to the 8th edition of AJCC) T3NanyM0 and confirmed on
imaging to fulfil at least any of the following: （1）MRF (+)，（2）EMVI（+），（3）LPLN（+）；or
T4NanyM0 with or without one of the above three;
6. Those who are expected to achieve R0 resection;
7. Able to swallow tablets normally;
8. Patients with the ECOG performance status of 0 or 1 at the time of enrollment;
9. Patients have not received any previous anti-tumor therapy for rectal cancer;
10. Planning to undergo surgery after completion of neoadjuvant therapy;
11. Have no contraindications to surgery;
12. Normal function of major organs, including:
1. Routine blood tests (no blood components, cell growth factors, leukocyte
boosters, platelet boosters, or anaemia-correcting drugs will be allowed within
14 days prior to the first dose of study drug):White blood cell count ≥ 4.0 x
109/L; Neutrophil count ≥ 1.5 x 109/L; Platelet count ≥100×109/L; Hemoglobin
≥90 g/L
2. Blood biochemistry: Total bilirubin ≤ 1.5 x ULN; ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN;
Serum creatinine ≤ 1.5 x ULN, or creatinine clearance ≥ 50 mL/min
(Cocheroft-Gault formula)
3. Coagulation: International normalised ratio (INR) ≤ 1.5 x ULN; Activated
partial thromboplastin time (APTT) ≤ 1.5×ULN
13. Female subjects of childbearing potential are required to have a negative serum
pregnancy test within 72 hours prior to initiation of study drug administration and
to use effective contraception (e.g., intrauterine device, birth control pills, or
condoms) during the trial period and for at least 3 months after the last dose of
study drug; for male subjects whose partner is a female of childbearing potential,
effective contraception should be used during the trial period and for 3 months
after the last dose of study drug; and for male subjects whose partner is a female
of childbearing potential, effective contraception should be used during the trial
period and for 3 months after the last dose of study drug. Use effective
contraception;
Exclusion Criteria:
1. A pre-existing history of allergy to monoclonal antibodies, any component of
camrelizumab, fluzoparib, capecitabine, oxaliplatin, or other platinum-based drugs;
2. Has received, or is receiving, any of the following prior treatments：a) Any
radiotherapy, chemotherapy, or other antineoplastic drug directed against the tumor;
b) Treatment with immunosuppressive drugs, or systemic hormonal drugs for
immunosuppression (doses > 10 mg/day prednisone or equivalent) within 2 weeks prior
to first use of study drug; inhaled or topical steroids and adrenocorticotropic
hormone replacement at doses > 10 mg/day prednisone or equivalent are permissible in
the absence of active autoimmune disease; c) Received a live attenuated vaccine
within 4 weeks prior to first use of study drug; d) Major surgery or severe trauma
within 4 weeks prior to first use of study drug;
3. Any active autoimmune disease or history of autoimmune disease including, but not
limited to: interstitial pneumonitis, enteritis, hepatitis, pituitary gland
inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be
considered for inclusion after hormone replacement therapy); patients with psoriasis
or childhood asthma/allergies that have been in complete remission and do not
require any intervention in adulthood may be considered for inclusion, but patients
requiring bronchial Medical intervention with bronchodilators may not be included;
4. A history of immunodeficiency, including a positive HIV test, or other acquired or
congenital immunodeficiency disease, or a history of organ transplantation or
allogeneic bone marrow transplantation;
5. Presence of cardiac clinical conditions or diseases that are not well controlled,
including, but not limited to, such as (1) NYHA Class II or higher heart failure,
(2) unstable angina pectoris, (3) myocardial infarction within 1 year, and (4)
clinically significant supraventricular or ventricular arrhythmia that is not
clinically intervened with or that remains poorly controlled after clinical
intervention;
6. A serious infection (CTCAE > grade 2) within 4 weeks prior to first use of study
drug, such as severe pneumonia, bacteremia, or infectious co-morbidities requiring
hospitalisation; except for prophylactic antibiotics if baseline chest imaging
suggests active lung inflammation, signs and symptoms of infection within 14 days
prior to first use of study drug, or if oral or intravenous antibiotic therapy is
required ;
7. The presence of active tuberculosis infection by history or CT scan, or a history of
active tuberculosis infection within 1 year prior to enrolment, or a history of
active tuberculosis infection more than 1 year ago without regular treatment
8. Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C
(hepatitis C antibody positive and HCV RNA above the lower detection limit of the
analytical method);
9. Other malignancies diagnosed within 5 years prior to the first use of study drug,
unless malignancies with a low risk of metastasis or risk of death (5-year survival
>90%), such as adequately treated basal cell carcinoma of the skin or squamous cell
skin carcinoma or carcinoma in situ of the uterine cervix, may be considered for
enrolment;
10. Women during pregnancy or lactation;
11. In the judgement of the investigator, the presence of other factors that may lead to
forced termination of the study in the middle of the study, such as the presence of
other serious illnesses (including psychiatric illnesses) that require comorbid
treatment, alcoholism, drug abuse, family or social factors that may affect the
safety of or compliance with the subject.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji hospital, Tongji Medical College of Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Contact:
Last name:
xianglin yuan
Start date:
June 28, 2023
Completion date:
June 28, 2026
Lead sponsor:
Agency:
Huazhong University of Science and Technology
Agency class:
Other
Source:
Huazhong University of Science and Technology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06516445
