NCT07819604尚未招募2 期
A Single-Arm, Phase II, Multicenter Study of Serplulimab Combined With CAPOX Plus Bevacizumab as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
Xijing Hospital0 个研究点目标入组 85 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 85
- 主要终点
- Pathological Complete Response (pCR) Rate
研究概览
简要总结
This is an exploratory study to evaluate the efficacy and safety of neoadjuvant therapy with serplulimab combined with CAPOX and bevacizumab for patients with locally advanced colorectal cancer. The primary endpoint is pathological complete response (pCR). Secondary efficacy endpoints include major pathological response (MPR), R0 resection rate, tumor down-staging, objective response rate (ORR), disease-free survival (DFS), and quality of life, to demonstrate clinical benefit of this combination regimen in the target patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily provide written informed consent prior to screening.
- •Male or female subjects aged ≥18 years.
- •At least one measurable lesion per RECIST 1.1 criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Histologically or pathologically confirmed locally advanced rectal adenocarcinoma, cT3/cT4N+M0 stage per AJCC/UICC 8th edition, with distance from anal verge ≤10 cm. Diagnosis is confirmed by contrast-enhanced CT/MRI, supplemented by colonoscopy and diagnostic laparoscopy if necessary; no prior anti-tumor treatment.
- •Scheduled for surgical resection following neoadjuvant therapy based on clinical staging.
- •Expected survival of more than 3 months.
- •No emergency indications such as bowel obstruction, bleeding or perforation.
- •Adequate major organ function as follows (no blood transfusion, granulocyte-colony stimulating factor (G-CSF) or other hematopoietic growth factor support within 14 days prior to screening):
- •Hematology: Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L, white blood cell count ≥3.5×10⁹/L.
- •Liver function: ALT and AST ≤2.5×ULN; total bilirubin ≤1.5×ULN (≤3×ULN for patients with Gilbert syndrome).
- •Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min.
- •Coagulation function: APTT, INR, PT ≤1.5×ULN.
排除标准
- •Prior anti-tumor therapy including chemotherapy, radiotherapy, hormonal therapy or molecular-targeted therapy.
- •Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or other agents targeting T-cell co-stimulatory or immune-checkpoint pathways.
- •History of other malignant tumors within 5 years or concurrent other malignancies, except for cured carcinoma in situ of cervix, non-melanoma skin cancer, or other malignancies with ≥5 years disease-free survival after curative treatment.
- •Peripheral neuropathy ≥Grade 2 per NCI-CTCAE v5.
- •Known active central nervous system metastases and/or carcinomatous meningitis.
- •History of severe hypersensitivity reaction (NCI-CTCAE v5.0 ≥Grade 3) to anti-PD-1 monoclonal antibodies, other monoclonal antibodies, oxaliplatin, S-1 or related compounds.
- •History of hereditary bleeding disorders or coagulopathy with high bleeding risk.
- •Major surgical procedure within 4 weeks prior to screening.
- •Not recovered from prior surgical complications with residual toxicity >Grade 1 (NCI-CTCAE v5.0), excluding alopecia and fatigue.
- •Requirement for immunosuppressive medication within 2 weeks before screening or during study treatment, except for:
- •Intranasal, inhaled, topical or intra-articular corticosteroids.
- •Physiological-dose systemic corticosteroids (≤10 mg/day prednisone or equivalent).
- •Short-term (≤7 days) corticosteroids for prophylaxis or treatment of non-autoimmune allergic conditions.
- •Active or history of recurrent autoimmune disease.
- •History of interstitial lung disease or non-infectious pneumonitis.
- •Known active tuberculosis (Mycobacterium tuberculosis) infection.
- •Human immunodeficiency virus (HIV) positive, other acquired or congenital immunodeficiency, history of organ transplantation or stem-cell transplantation.
- •Hepatitis B or C virology findings at screening meeting any of the following:
- •HBsAg-positive with HBV-DNA ≥10⁴ copies/mL or ≥2000 IU/mL (antiviral therapy may be administered for HBV carriers at investigator's discretion).
- •Active hepatitis C: HCV-antibody-positive with detectable HCV-RNA above assay lower limit.
- •Active or uncontrolled infection requiring systemic therapy within 2 weeks prior to screening.
- •Receipt of live-virus vaccine within 4 weeks prior to screening.
- •Bowel obstruction, or history of inflammatory bowel disease, extensive bowel resection with chronic diarrhea, Crohn's disease, ulcerative colitis or chronic diarrhea.
- •Lactating females, or females planning pregnancy during study treatment or within 6 months after treatment completion.
- •Subjects (fertile males, females and their male partners) unwilling to use effective contraception during study treatment and for 6 months after treatment completion.
- •Any other condition that, in the investigator's opinion, would compromise study compliance or outcome assessment, making the subject unsuitable for study participation.
研究组 & 干预措施
Serplulimab plus CAPOX and Bevacizumab Neoadjuvant Treatment
Experimental
干预措施: CAPOX (Drug)
Serplulimab plus CAPOX and Bevacizumab Neoadjuvant Treatment
Experimental
干预措施: Serplulimab (Drug)
Serplulimab plus CAPOX and Bevacizumab Neoadjuvant Treatment
Experimental
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Pathological Complete Response (pCR) Rate
时间窗: Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)
Percentage of patients who achieve pathological complete response, defined as no residual viable tumor cells in the resected surgical specimen.
次要结局
- Disease-Free Survival (DFS)(Up to 36 months after surgical resection)
- Major Pathological Response (MPR) Rate(Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection))
- R0 Resection Rate(Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection))
- Tumor Down-staging Rate(Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection))
- Objective Response Rate (ORR)(Up to 6 weeks after completion of neoadjuvant therapy (prior to surgical resection))
研究者
相似试验
招募中
2 期
Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT)NCT07283692RenJi Hospital46
招募中
2 期
Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%NSCLC (Non-small Cell Lung Cancer)NCT07596121Tang-Du Hospital60
尚未招募
2 期
Neoadjuvant Therapy With Iparomlimab and Tuvonralimab, Lenvatinib and Chemotherapy in Resectable ESCCEsophageal Squamous CarcinomaNCT07490002Changhai Hospital33
尚未招募
2 期
Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast CancerInvasive Breast Cancer (Stage I-III)NCT07801898The Second Hospital of Anhui Medical University36
尚未招募
2 期
Pembrolizumab Plus Belzutifan With or Without Lenvatinib in Localized Renal Cell CarcinomaRenal Cell CarcinomaNCT07593040Vall d'Hebron Institute of Oncology150