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Trial Title:
PD1 Antibody Combined With mFOLFOX6 Neoadjuvant Therapy for Advanced Resectable Metastatic Colon Cancer
NCT ID:
NCT06335147
Condition:
Metastatic Colon Cancer
Conditions: Official terms:
Colonic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Serplulimab, mFOLFOX6
Description:
Serplulimab,200mg,iv,q2w,d1; mFOLFOX6(Oxaliplatin: 85 mg/m2,LV :400mg/m2,Fluorouracil:
400mg/m2 d1,2400 mg/m2 continuous intravenous drip for 46-48 hours;q2w)
Arm group label:
Serplulimab, mFOLFOX6
Other name:
HLX10
Summary:
Evaluate the efficacy and safety of PD1 monoclonal antibody combined with mFOLFOX6
neoadjuvant therapy for advanced resectable metastatic colon cancer with enriched
pro-inflammatory pan macrophage subpopulations
Detailed description:
In this study, patients with advanced resectable metastatic colon cancer requiring
neoadjuvant chemotherapy were selected, and colon cancer patients enriched with
TNFSF10+CXCL10+ panTAMs subgroup were screened, and neoadjuvant chemotherapy was
performed with PD-1 monoclonal antibody combined with chemotherapy. To evaluate the
efficacy and safety of PD-1 monoclonal antibody combined with neoadjuvant chemotherapy in
the treatment of special types of colon cancer.
All patients in this study were examined in the tumor microenvironment before treatment,
and only patients enriched with TNFSF10+CXCL10+ panTAMs subgroup were enrolled in the
study. Due to the long detection time, the patient received mFOLFOX6 chemotherapy for one
week in the first cycle. If the test results meet the enriched proinflammatory
panmacrophage subpopulation, patients can eventually be enrolled and receive PD-1
monoclonal antibody (Serplulimab, Srulimab) combined with mFOLFOX6 (oxaliplatin,
fluorouracil) regimen, 2 weeks for 1 cycle. The primary radical resection was performed
after 5 cycles of neoadjuvant therapy. Local treatment of liver/lung metastases was
performed at the same time or at different times. Continue mFOLFOX6 chemotherapy for 4-6
cycles or CAPEOX regimen for 4 cycles within 1-2 months after surgery. Liver and lung
metastases allow local treatment in any of these treatment cycles, including but not
limited to radiofrequency ablation, particle implantation, radiation therapy, and
surgery. At the end of postoperative adjuvant therapy, NED status was achieved. Then,
regular follow-up.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Signed the inform consent
- Age >=18 years old, female and male
- Locally advanced or metastatic colorectal adenocarcinoma (including sig-ring cell
carcinoma, mucinous adenocarcinoma, etc.) confirmed by pathology (histology or
cytology)
- Enriched with proinflammatory panmacrophage subsets
- At least one measurable or evaluable lesion according to RECIST 1.1; Measurable
lesions should not have received local treatment such as radiotherapy (Metastases
can still be used as target lesions to evaluate efficacy after biopsy.
Periintestinal lymph node imaging determines metastasis, allowing for a minimum
diameter of ≥ 10mm, and can also be used as target lesions.)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- The life expectancy is ≥6 months;And according to the MDT in the hospital, only
neoadjuvant chemotherapy is needed
- Hemoglobin content (HB) ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5 ×
109/L;Platelet count (PLT) ≥ 100 × 109/L (did not use interleukin-11 or TPO within
14 days);White blood cell count (WBC) ≥ 4.0 × 109/L (no use of granulocyte
stimulating factor within 14 days).
- Total serum bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); ALT
and AST ≤ 2.5 × ULN;Cr ≤ 1.5 × ULN or creatinine clearance rate (CCr) ≥ 60ml/min,
(Cockcroft Gault formula);Serum albumin ≥ 25 g/L (2.5 g/dL)
- For liver metastasis subjects, AST and ALT must be ≤ 5 x ULN, and white blood cells
must be ≥ 4 × 109/L, platelets without blood transfusion ≥ 100 × 109/L, absolute
neutrophil count (ANC) ≥ 1.5 without granulocyte stimulating factor treatment ×
109/L, hemoglobin ≥ 90 g/L
- Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ lower
limit of normal value (50%).
- Adequate coagulation function, defined as international standardized ratio (INR) or
prothrombin time (PT) ≤ 1.5 times ULN;
Exclusion Criteria:
- Allergy to any investigational drug or its excipients, or a history of severe
allergies, or contraindications to investigational drugs;
- Having a history of autoimmune diseases or being in an active phase;
- Symptomatic/Asymptomatic Brain Metastasis
- CT indicates clear ulcerative lesions or fecal occult blood positive for three or
more consecutive times, and clinical considerations suggest the presence of
gastrointestinal bleeding
- Abnormal thyroid function or taking thyroxine tablets
- Previously received allogeneic bone marrow transplantation or organ transplantation;
- Congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or CT
confirmed active pneumonia;
- HIV positive, active hepatitis B or C, active pulmonary tuberculosis;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 1, 2024
Completion date:
January 31, 2026
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06335147