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TPF+CCRT
TPF+CCRT is a Chemotherapy regimen Small molecule drug developed by Guiyang Medical University. It is currently in Phase 3 development for Locally advanced or metastatic squamous cell carcinoma of the head and neck, Locally advanced or metastatic non-small cell lung cancer. Also known as: Experimental group, Control group, TPF induction chemotherapy.
TPF+CCRT is a chemotherapy regimen that combines docetaxel, cisplatin, and fluorouracil to target rapidly dividing cancer cells.
The TPF+CCRT (Docetaxel, Cisplatin, and Fluorouracil with Concurrent Chemoradiotherapy) regimen is being studied in clinical trials for various head and neck cancers, including Nasopharyngeal Carcinoma, Locally Advanced Nasopharyngeal Carcinoma, and Locally Advanced Head and Neck Squamous Cell Carcinoma. This regimen typically involves Cisplatin-based induction chemotherapy, followed by a full course of PD-1/PD-L1 blockades and Reduced-dose IMRT (Intensity-Modulated Radiation Therapy).
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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 | TPF+CCRT |
|---|---|
| Also known as | Experimental group, Control group, TPF induction chemotherapy |
| Sponsor | Guiyang Medical University |
| Drug class | Chemotherapy regimen |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This regimen works by inhibiting cell division and inducing apoptosis in cancer cells. Docetaxel and cisplatin interfere with microtubule function and DNA replication, respectively, while fluorouracil inhibits thymidylate synthase, leading to DNA damage and cell death.
Approved indications
- Locally advanced or metastatic squamous cell carcinoma of the head and neck
- Locally advanced or metastatic non-small cell lung cancer
Common side effects
- Neutropenia
- Anemia
- Thrombocytopenia
- Nausea and vomiting
- Diarrhea
Key clinical trials
- Study of MRI Guided Personal Chemoradiotherapy and Immunotherapy for Limited Advanced Esophageal Squamous Caicinoma. (PHASE2)
- Induction Modified TPF Followed by Concurrent Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (PHASE2)
- Concurrent Chemoradiotherapy With Nimotuzumab for High Risk Nasopharyngeal Carcinoma (PHASE2)
- Reduced-dose RT With/Without CCT Versus Standard CCRT for High-risk LANPC Who Achieved CR Post Induction Chemotherapy (PHASE3)
- TPF+CCRT vs.CCRT+PF in High Risk Nasopharyngeal Carcinoma (PHASE3)
- Induction Chemotherapy Plus Radiotherapy Alone in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma (PHASE3)
- Neoadjuvant Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN) (PHASE2)
- GP Induction Chemotherapy us TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC (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:
- TPF+CCRT CI brief — competitive landscape report
- TPF+CCRT updates RSS · CI watch RSS
- Guiyang Medical University portfolio CI
Frequently asked questions about TPF+CCRT
What is TPF+CCRT?
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Related
- Drug class: All Chemotherapy regimen drugs
- Manufacturer: Guiyang Medical University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Locally advanced or metastatic squamous cell carcinoma of the head and neck
- Indication: Drugs for Locally advanced or metastatic non-small cell lung cancer
- Also known as: Experimental group, Control group, TPF induction chemotherapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing