NCT07129772

Perioperative Chemotherapy and Immunotherapy for Locally Recurrent Nasopharyngeal Carcinoma

Not yet recruiting Phase 2 Last updated 4 September 2025

What this trial tests

Phase 2 trial testing Gemcitabine (GEM) in Nasopharyngeal Cancer Recurrent in 53 participants. Not yet recruiting.

Timeline

1 November 2025

Primary endpoint
31 December 2027

30 June 2028

Quick facts

Lead sponsor	The University of Hong Kong
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	53
Start date	1 November 2025
Primary completion	31 December 2027
Estimated completion	30 June 2028
Sites	1 location across Hong Kong

Drugs / interventions tested

• Gemcitabine (GEM) — full drug profile →
• Cisplatin (cisplatin) — full drug profile →
• PEMBROLIZUMAB (alone or when added to a regimen above) — full drug profile →

Conditions studied

• Nasopharyngeal Cancer Recurrent — all drugs for Nasopharyngeal Cancer Recurrent →
• Nasopharyngeal Cancinoma (NPC) — all drugs for Nasopharyngeal Cancinoma (NPC) →

Sponsor

The University of Hong Kong

Who can join

18 and older, any sex, with Nasopharyngeal Cancer Recurrent or Nasopharyngeal Cancinoma (NPC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Nasopharyngeal carcinoma (NPC) is an endemic malignancy in Southern China and southeast Asia. Despite intensive radical therapy, between 15% and 30% of NPC patients develop relapse. Recent phase III randomized-controlled trials conducted in China demonstrated an improvement of progression-free survival with combinational therapy immune checkpoint inhibitors (ICI) (camrelizumab, toripalimab, and tislelizumab, respective) and chemotherapy gemcitabine (G) and cisplatin (P) compared with chemotherapy GP alone for recurrent or metastatic NPC. However, none of these studies have described in details the treatment outcomes of those subjects with locally recurrent NPC only, and whether any of these patients would undergo radical surgery to remove the residual locally recurrent NPC after ICI and chemotherapy. Continuation of the same ICI as maintenance therapy may only be the treatment option for these patients who were recruited into these phase III trials, unless if they withdrew from the study and opted for radical resection. While continuing the same ICI may still lead to persistent objective response and disease control, there is a possibility of tumor recurrence leading to unresectable disease and a worse survival outcome, or unexpected, rare but recognized immune-related emergent adverse events with ICI. Radical resection after maximal response to ICI and chemotherapy for patients with locally recurrent NPC only may provide a chance of cure of the disease and these patients may be obviated from continuous exposure to ICI therapy.

In view of the above, we are now proposing a phase II single-arm study on perioperative pembrolizumab and chemotherapy followed by radical surgery for locally recurrent NPC. As a collateral study, we will also perform single-cell DNA and RNA sequencing and proteomics study to observe the tumor and immune microenvironment which certainly helps us decipher the mechanisms of tumor response at genomic, transcriptomic and proteomic levels.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.