PD1 Antibody Combined With mFOLFOX6 Neoadjuvant Therapy for Advanced Resectable Metastatic Colon Cancer

NCT06335147 | Unknown

• 1 other identifier: HLX10IIT114
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Metastatic Colon Cancer

Outcome Measures

Primary Outcomes (1)

• pathologic complete response（pCR）

  pCR is defined as the percentage of participants in the analysis population who have a pathologic complete response

  1 month after resection

Secondary Outcomes (3)

• Objective response rate (ORR)

  1 month after resection

• 2-year overall survival rate

  2-year

• Incidence of Treatment-Emergent Adverse Events

  up to 6 months

Study Arms (1)

Serplulimab, mFOLFOX6

EXPERIMENTAL

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）

Drug: Serplulimab, mFOLFOX6

Interventions

Serplulimab, mFOLFOX6 DRUG

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）

Also known as: HLX10

Serplulimab, mFOLFOX6

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Suxia Luo

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Li

CONTACT

0086-13526501903; lining97@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 28, 2024
• Study Start: April 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: March 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share