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Docetaxel, cisplatin and fluorouracil
Docetaxel, cisplatin and fluorouracil is a Combination chemotherapy (taxane + platinum + antimetabolite) Small molecule drug developed by Sun Yat-sen University. It is currently in Phase 3 development for Advanced gastric cancer, Head and neck cancer, Esophageal cancer. Also known as: TPF induction chemotherapy.
This combination chemotherapy regimen uses three cytotoxic agents to inhibit cancer cell division and induce apoptosis through different mechanisms.
Docetaxel, cisplatin, and fluorouracil are small molecule chemotherapeutic agents used to treat various types of cancer, including sinonasal tumors, tongue neoplasms, and squamous cell carcinoma. These agents are studied in clinical trials for conditions such as anterior tongue squamous cell carcinoma and neoplasms.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Docetaxel, cisplatin and fluorouracil |
|---|---|
| Also known as | TPF induction chemotherapy |
| Sponsor | Sun Yat-sen University |
| Drug class | Combination chemotherapy (taxane + platinum + antimetabolite) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Docetaxel is a taxane that stabilizes microtubules and prevents cell division; cisplatin is a platinum agent that cross-links DNA and causes strand breaks; and fluorouracil (5-FU) is an antimetabolite that inhibits thymidylate synthase and disrupts nucleotide synthesis. Together, these agents provide synergistic cytotoxic effects against rapidly dividing cancer cells.
Approved indications
- Advanced gastric cancer
- Head and neck cancer
- Esophageal cancer
Common side effects
- Neutropenia
- Anemia
- Thrombocytopenia
- Nausea and vomiting
- Mucositis
- Diarrhea
- Peripheral neuropathy
- Alopecia
- Fatigue
Key clinical trials
- Durvalumab in Combination With Docetaxel, Cisplatin and 5-FU for Locally Advanced Head and Neck Squamous Cell Carcinoma (PHASE1)
- Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585) (PHASE3)
- Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)-China Extension (PHASE3)
- Docetaxel, Cisplatin and Fluorouracil in Treating Patients With Previously Untreated Stage II-IV Nasal Cavity and Paranasal Sinus Cancer (PHASE2)
- Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (PHASE3)
- A Study of ASP3082 in Adults With Advanced Solid Tumors (PHASE1)
- A Phase II Trial Comparing Immunotherapy Versus Capecitabine Maintenance After Chemo-chemoradiotherapy for High-risk Nasopharyngeal Carcinoma (PHASE2)
- Neoadjuvant Treatment of Toripalimab Combined With Nab-paclitaxel and Platinum Versus Neoadjuvant Docetaxel Combined With Cisplatin and 5-fluorouracil (DCF) in Esophageal Squamous Cell Carcinoma (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Docetaxel, cisplatin and fluorouracil CI brief — competitive landscape report
- Docetaxel, cisplatin and fluorouracil updates RSS · CI watch RSS
- Sun Yat-sen University portfolio CI
Frequently asked questions about Docetaxel, cisplatin and fluorouracil
What is Docetaxel, cisplatin and fluorouracil?
How does Docetaxel, cisplatin and fluorouracil work?
What is Docetaxel, cisplatin and fluorouracil used for?
Who makes Docetaxel, cisplatin and fluorouracil?
Is Docetaxel, cisplatin and fluorouracil also known as anything else?
What drug class is Docetaxel, cisplatin and fluorouracil in?
What development phase is Docetaxel, cisplatin and fluorouracil in?
What are the side effects of Docetaxel, cisplatin and fluorouracil?
Related
- Drug class: All Combination chemotherapy (taxane + platinum + antimetabolite) drugs
- Manufacturer: Sun Yat-sen University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced gastric cancer
- Indication: Drugs for Head and neck cancer
- Indication: Drugs for Esophageal cancer
- Also known as: TPF induction chemotherapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing