Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
The combination of 5-fluorouracil (5-FU) and cisplatin has been used as a chemotherapy regimen for various cancers, particularly head and neck cancers and anal cancers. Toripalimab is a newer PD-1 inhibitor that was approved by the FDA in October 2023 for nasopharyngeal carcinoma (NPC). ## Drug Components **5-Fluorouracil (5-FU)** 5-Fluorouracil is a chemotherapy drug that destroys quickly dividing cells, such as cancer cells[1]. It's administered intravenously, often through a central line, PICC line, or portacath[1]. **Cisplatin** Cisplatin is also a chemotherapy drug that works by destroying quickly dividing cells[1]. It's typically administered as a drip for between 1 and 8 hours, with extra fluids given before and after to protect the kidneys[1]. **Toripalimab** Toripalimab is a PD-1 blocking antibody that works by blocking the PD-L1/PD-1 pathway, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response[6]. It was approved by the FDA in October 2023 for nasopharyngeal carcinoma[4][5]. ## Therapeutic Use While the specific combination of all three drugs (5-fluorouracil + cisplatin + toripalimab) is not explicitly mentioned in the search results, we can understand their potential combined use based on their individual mechanisms and approved indications: 1. 5-FU and cisplatin combination has shown effectiveness in: - Recurrent and disseminated epidermoid cancer of the head and neck with a 70% overall response rate[2] - Metastatic anal cancer with a 66% response rate[3] 2. Toripalimab was approved: - In combination with cisplatin and gemcitabine for first-line treatment of metastatic or recurrent locally advanced nasopharyngeal carcinoma[4][5] - As a single agent for recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy[4][5] ## Administration and Dosing For the individual components: - 5-FU is typically administered as a continuous infusion for 4-5 days or continuously for 21 days[1][3] - Cisplatin is usually given as a 100 mg/m² IV bolus on day 1 with hydration and mannitol diuresis[2][3] - Toripalimab's recommended dosage is: - 240 mg every three weeks when used in combination therapy until disease progression, unacceptable toxicity, or up to 24 months[7] - 3 mg/kg every two weeks as a single agent until disease progression or unacceptable toxicity[7] ## Side Effects Common side effects of these drugs include: - For 5-FU and cisplatin: increased risk of infection, breathlessness, bruising and bleeding, changes to mineral levels in blood[1] - For toripalimab combination therapy: nausea, vomiting, decreased appetite, constipation, hypothyroidism, rash, pyrexia, diarrhea, peripheral neuropathy, cough, musculoskeletal pain, upper respiratory infection, insomnia, dizziness, and malaise[5] This combination represents an approach that combines traditional chemotherapy (5-FU and cisplatin) with modern immunotherapy (toripalimab), potentially offering enhanced efficacy through complementary mechanisms of action.
Beyond the preview
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Follow clinical development from study design and recruitment through results.
Explore development by indication, patient population, and geography.
Trace asset ownership, licensing agreements, and commercial partnerships.
Explore the patent landscape and regulatory exclusivity around an asset.
Compare development programs by target, modality, and indication.
Connect source evidence and development news to your research questions.
See how Gosset can support your research on 5-fluorouracil + cisplatin + toripalimab.