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NCT02285530
GDF15 Based TPF Induction Chemotherapy for OSCC Patients
Status unknown
Phase 2
Last updated 5 April 2023
What this trial tests
Phase 2 trial testing TPF induction chemotherapy in Mouth Neoplasms in 72 participants. Status unknown.
Timeline
1 December 2019
Primary endpoint
31 December 2023
31 December 2023
31 December 2025
Quick facts
| Lead sponsor | Shanghai Jiao Tong University School of Medicine |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 1 December 2019 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- TPF induction chemotherapy — full drug profile →
- surgery group
- Post-operative radiotherapy
Conditions studied
- Mouth Neoplasms — all drugs for Mouth Neoplasms →
- Carcinoma, Squamous Cell — all drugs for Carcinoma, Squamous Cell →
Sponsor
Shanghai Jiao Tong University School of Medicine
Who can join
Adults 18 to 75, any sex, with Mouth Neoplasms or Carcinoma, Squamous Cell. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to confirm the predictive value of GDF15 expression for TPF induction in T3/T4cN0M0 patients with OSCC
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pathophysiological role of growth differentiation factor 15 (GDF15) in obesity, cancer, and cachexia.
Siddiqui JA, Pothuraju R, Khan P, Sharma G, et al · · 2022 · cited 134× · PMID 34836750 · DOI 10.1016/j.cytogfr.2021.11.002 -
GDF15/GFRAL Pathway as a Metabolic Signature for Cachexia in Patients with Cancer.
Ahmed DS, Isnard S, Lin J, Routy B, et al · · 2021 · cited 49× · PMID 33442410 · DOI 10.7150/jca.50376 -
Interventions for the treatment of oral cavity and oropharyngeal cancer: chemotherapy.
Parmar A, Macluskey M, Mc Goldrick N, Conway DI, et al · · 2021 · cited 43× · PMID 34929047 · DOI 10.1002/14651858.cd006386.pub4 -
Long-term results of a randomized phase III trial of TPF induction chemotherapy followed by surgery and radiation in locally advanced oral squamous cell carcinoma.
Zhong LP, Zhang CP, Ren GX, Guo W, et al · · 2015 · cited 40× · PMID 26124084 · DOI 10.18632/oncotarget.4531 -
Mechanism of sensitivity to cisplatin, docetaxel, and 5-fluorouracil chemoagents and potential erbB2 alternatives in oral cancer with growth differentiation factor 15 overexpression.
Zhao TC, Zhou ZH, Ju WT, Liang SY, et al · · 2022 · cited 15× · PMID 34826159 · DOI 10.1111/cas.15218 -
Elevated growth differentiating factor 15 expression predicts long-term benefit of docetaxel, cisplatin and 5-fluorouracil induction chemotherapy in patients with oral cancer.
Tang X, Hu YJ, Ju WT, Fu Y, et al · · 2018 · cited 11× · PMID 29731919 · DOI 10.3892/ol.2018.8324 -
The Multifaceted Role of Growth Differentiation Factor 15 (GDF15): A Narrative Review from Cancer Cachexia to Target Therapy.
Filippini DM, Romaniello D, Carosi F, Fabbri L, et al · · 2025 · cited 4× · PMID 40868185 · DOI 10.3390/biomedicines13081931
Verify or expand the search:
- PubMed search for NCT02285530
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TPF induction chemotherapy
Trials testing the same drug.
- NCT02285543 — A Phase II Trial of TPF Induction Chemotherapy in cN2 OSCC Patients · Phase 2 · terminated
Other recruiting trials for Mouth Neoplasms
Currently open trials in the same condition.
- NCT07401641 — Effect of Dezocine Versus Nalbuphine Combined With Sufentanil on Postoperative Analgesia, Complications, and Free Flap S · NA · recruiting
- NCT05296941 — Oral Cancer Screening for Early Detection of Premalignant Disorders (PMOD) · NA · recruiting
Other Shanghai Jiao Tong University School of Medicine trials
Trials by the same sponsor.
- NCT07570810 — Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM · NA · not yet recruiting
- NCT07528079 — Organoid-based Sensitivity-guided Chemotherapy for Advanced / Refractory Pediatric Tumors · NA · enrolling by invitation
- NCT07535710 — Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Treated Cutaneous T-ce · Phase 1, PHASE2 · not yet recruiting
- NCT07535762 — Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Untreated Peripheral T · Phase 2 · not yet recruiting
- NCT07350057 — A Preliminary Clinical Study on the Efficacy of Cyclophosphamide and Sirolimus Combined With VIC-1911 in Preventing Graf · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02285530 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Jiao Tong University School of Medicine
- Last refreshed: 5 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02285530.
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