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NCT06664983
TPC Combined With Cadonilimab VS. TPC Alone in Anti-PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma
Phase 3 trial testing TPC chemotherapy in Nasopharyngeal Cancinoma (NPC) in 84 participants. Participants enrolled and being followed up; not accepting new ones.
21 October 2025
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 84 |
| Start date | 21 October 2024 |
| Primary completion | 21 October 2025 |
| Estimated completion | 21 October 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- TPC chemotherapy — full drug profile →
- cadonilimab combined TPC chemotherapy — full drug profile →
Conditions studied
- Nasopharyngeal Cancinoma (NPC) — all drugs for Nasopharyngeal Cancinoma (NPC) →
Sponsor
Sun Yat-sen University
Who can join
Adults 18 to 70, any sex, with Nasopharyngeal Cancinoma (NPC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
With the advancement of large-scale phase III clinical studies such as RATIONALE-309, JUPITER-02, and CAPTAIN-1, the GP regimen combined with immunotherapy has become the recommended first-line treatment for recurrent metastatic nasopharyngeal carcinoma. However, patients receiving first-line chemotherapy plus immunotherapy have a median progression-free survival time of only 9.6 to 21.4 months, indicating that disease progression is still inevitable after first-line chemo-immunotherapy in patients with recurrent/metastatic nasopharyngeal carcinoma. Therefore, second or subsequent line treatment options are crucial for the management of patients with recurrent/metastatic nasopharyngeal carcinoma. In 2021, the International Society for Cancer Immunotherapy reported a multicenter, open-label, single-arm phase II clinical study of cadonilimab in patients with metastatic nasopharyngeal carcinoma who had failed second-line or subsequent chemotherapy. The data showed that among the 20 evaluable patients enrolled, the objective response rate for cadonilimab monotherapy reached 30%, with a disease control rate of 70%, and the median progression-free survival time was 3.71 months. These study results suggest that cadonilimab demonstrates encouraging anti-tumor activity and good safety in patients with metastatic nasopharyngeal carcinoma who have failed second-line or subsequent chemotherapy.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Albumin-based nanocarriers: Singularities, synthesis methods, clinical relevance and targeting strategies in cancer.
Pérez-Herrero E, Fernández-Medarde A, Irache JM. · · 2026 · cited 1× · PMID 42039283 · DOI 10.1016/j.apsb.2025.11.035 -
A Canadian Perspective on Systemic Therapy for Recurrent or Metastatic Nasopharyngeal Carcinoma.
Spreafico A, Winquist E, Ho C, O'Sullivan B, et al · · 2025 · PMID 39851964 · DOI 10.3390/curroncol32010048
Verify or expand the search:
- PubMed search for NCT06664983
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Nasopharyngeal Cancinoma (NPC)
Currently open trials in the same condition.
- NCT07362979 — Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal C · Phase 2 · recruiting
- NCT07496190 — Becotatug Vedotin for LA-NPC With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy · Phase 2 · recruiting
- NCT07325539 — LDRT Combined With Toripalimab and Chemotherapy for Recurrent/Metastatic NPC · Phase 2 · recruiting
- NCT07376603 — IMRT Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features · recruiting
- NCT07311772 — Prevention and Treatment of Radiation-Induced Oral Mucositis in NPC With Houyanqing Oral Liquid · Phase 3 · recruiting
Other Sun Yat-sen University trials
Trials by the same sponsor.
- NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
- NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
- NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
- NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
- NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · NA · 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)
- Trial protocol + status: ClinicalTrials.gov NCT06664983 (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 Sun Yat-sen University
- Last refreshed: 30 October 2024
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/NCT06664983.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing