SHR-1701 Combined with SHR2554 and BP102 for MCRC

Официальное название

An Explorative Study of SHR-1701 Combined with SHR2554 and BP102(bevacizumab) for Metastatic Colorectal Cancer.

Обзор

Response to oncologic treatment in mCRC is currently limited.

Подробное описание

This is a single-center, open-labeled study exploring the efficacy and safety of SHR-1701 combined with SHR2554 and BP102 in the treatment of metastatic colorectal cancer (mCRC) .

Вмешательства

• Препарат SHR-1701
  SHR-1701
• Препарат BP102
  BP102
• Препарат SHR2554
  SHR2554

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: assessed up to 1 year]

Вторичные конечные точки (3)

• Disease Control Rate (DCR) [Срок оценки: assessed up to 1 year]
• Progression-Free Survival (PFS) [Срок оценки: assessed up to 1 year]
• Overall survival (OS) [Срок оценки: assessed up to 2 year]

Критерии участия

Критерии включения

• 18-75 years;
• Histological confirmed metastatic colorectal cancer;
• ECOG PS 0-1;
• At least one measurable lesion (according to RECIST1.1);
• Adequate hepatic, renal, coagulation, and hematologic functions;
• Agree to use contraception during the study and 3 months after the end of the study. Negative serum pregnancy test at screening for women of childbearing potential;
• Patients voluntarily enroll in the study.

Критерии исключения

• The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• Symptomatic brain or meningeal metastases (except for those whose BMS disease is stable for at least 4 weeks);
• Allergy to the study drug or any of its excipients;
• Prior treatment with immune checkpoint inhibitors;
• Received the following treatments before the first study treatment;

• Major surgery within 28 days before treatment (tissue biopsy for diagnostic purposes is permitted).
• Prior use of immunosuppressive medications, excluding nasal and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/d prednisone or equivalent pharmacologic doses of other corticosteroids) within 7 days before treatment;
• Received immunomodulatory drugs within 3 weeks before treatment;
• Received live attenuated vaccine within 28 days before treatment;
• Receipt of other antitumor systemic therapy within 28 days prior to treatment;
• Presence of any active autoimmune disease or history of autoimmune disease with expected relapse;
• A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
• Human immunodeficiency virus (HIV) infection or known AIDS, untreated active hepatitis, HBV-DNA ≥ 2500 IU/ml and abnormal liver function; hepatitis C or co-infection with hepatitis B and hepatitis C;
• A history of interstitial lung disease or non-infectious pneumonia, etc.;
• Within 6 months before enrollment, the following conditions: myocardial infarction, severe/unstable angina, NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; hypertension with poorly controlled by medications;
• A history of severe bleeding within 3 months (>30 ml at a time) or hemoptysis within 1 month (>5 ml at a time) or a thromboembolic event (including pulmonary embolism, cerebral infarction, etc.) within 12 months;
• Surgical treatment (except biopsy) within 6 weeks or unhealed surgical incision;
• Long-standing unhealed wounds or fractures that have not healed properly
• Imaging showing that the tumor has invaded a vital vascular perimeter or if, in the judgment of the investigator, the patient's tumor has a very high likelihood of invading a vital blood vessel and causing a fatal hemorrhage during therapy
• A history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active gastrointestinal bleeding within 6 months before the first study treatment
• Urine routine showed urine protein ≥2+, and 24-hour urine protein level >1.0g;
• Unable to take the drug orally, or has a condition judged by the investigator to affect the absorption of the drug;
• Pregnancy, lactation, and unwillingness of reproductively active subjects to use effective contraception;
• Other conditions deemed by the investigator to be ineligible for inclusion in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Colorectal Surgery Fudan University Shanghai Caner Center — Шанхай

Идентификаторы

NCT: NCT06679673 · CRC-IIT-SHR1701-SHR2554-BP102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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