A Phase 2 interventional study of Toripalimab (240mg day1, Q3W*3cycle) and Cisplatin (80 mg/m2) in Nasopharyngeal Carcinoma (NPC), Radiation-induced Oral Mucositis and Head and Neck Neoplasms, sponsored by Affiliated Hospital of Guangdong Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Affiliated Hospital of Guangdong Medical University · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to learn if the balance of omega-6 and omega-3 fats in red blood cells can predict severe mouth sores caused by radiation therapy in people with locally advanced nasopharyngeal carcinoma (a type of head and neck cancer). The main questions it aims to answer are:
How does the n-6/n-3 fat ratio in red blood cells change during treatment?
Can the n-6/n-3 fat ratio measured before radiation therapy predict which patients will develop severe mouth sores (grade 3 or higher)?
Researchers will compare patients with healthy volunteers at the start of the study to see if their fat profiles and inflammation markers differ.
Participants will:
Receive immunotherapy (toripalimab) combined with chemotherapy (cisplatin and nab-paclitaxel), followed by radiation therapy with toripalimab.
Give blood samples at 7 time points before, during, and after treatment.
Have their mouth sores checked weekly during radiation therapy.
Complete nutritional assessments and questionnaires.
Background and rationale. Nasopharyngeal carcinoma (NPC) is endemic in Southeast Asia and southern China, and most patients are diagnosed with locally advanced disease. Standard treatment for locally advanced NPC (LA-NPC) includes induction chemotherapy followed by concurrent chemoradiotherapy. Although effective, this approach causes substantial acute toxicity, and radiation-induced oral mucositis (RIOM) remains the most common severe complication. PD-1 inhibitors have enabled cisplatin-sparing strategies that maintain efficacy while reducing toxicity, but RIOM is still a major clinical challenge. Omega-6 and omega-3 polyunsaturated fatty acids (PUFAs) have opposing roles in inflammation. The erythrocyte membrane n-6/n-3 PUFA ratio reflects systemic fatty acid balance and inflammatory status over the preceding 2-3 months. This ratio has been linked to chronic disease risk and cancer progression, but its longitudinal changes and relationship with RIOM have not been prospectively examined in LA-NPC patients receiving PD-1 inhibitor-based, cisplatin-sparing regimens.
Study design and setting. This is a prospective, single-center, single-arm interventional study conducted at the Affiliated Hospital of Guangdong Medical University. The study enrolled treatment-naïve patients with LA-NPC (AJCC 9th edition stage II-III) and matched healthy controls. All patients received protocol-directed therapy and were followed prospectively. Healthy controls provided a single blood sample at enrollment. The study was approved by the Ethics Committee of the Affiliated Hospital of Guangdong Medical University (approval no. LY2025-10-025) and conducted in accordance with the Declaration of Helsinki. The study was prospectively registered at ClinicalTrials.gov.
Treatment protocol. All enrolled patients received a three-stage treatment regimen. First, patients received three 21-day cycles of induction chemoimmunotherapy. On day 1 of each cycle, they received intravenous toripalimab 240 mg, cisplatin 80 mg/m², and nab-paclitaxel 260 mg/m². After induction, patients received concurrent toripalimab and intensity-modulated radiotherapy (IMRT). Target volumes included the gross tumor volume of the nasopharynx (GTVnx), gross tumor volume of metastatic lymph nodes (GTVnd), high-risk clinical target volume (CTV1), and low-risk clinical target volume (CTV2). GTVnx and GTVnd received 69.96 Gy, CTV1 received 60 Gy, and CTV2 received 54 Gy, given once daily, five days per week, for 33 fractions. During radiotherapy, patients received three cycles of toripalimab 240 mg every 21 days. After radiotherapy, patients received six 3-weekly cycles of adjuvant toripalimab 240 mg intravenously.
Sample collection and laboratory assessments. Blood samples were collected at seven prespecified time points: T0 (baseline, within 1 week before treatment), T1-T3 (within 3 days after each induction cycle), T4 (pre-radiotherapy, within 1 week before radiotherapy), T5 (mid-radiotherapy, cumulative dose 40 Gy, 19 fractions), T6 (post-radiotherapy, within 3 days after completion), and T7 (1 month after radiotherapy). Healthy controls provided a single sample at enrollment. Erythrocyte membrane fatty acids were quantified by gas chromatography. Individually quantified omega-6 PUFAs were linoleic acid (LA), arachidonic acid (AA), and docosatetraenoic acid (DTA). Individually quantified omega-3 PUFAs were α-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). Total omega-6 and total omega-3 PUFAs were calculated as the sum of identified fatty acids. The n-6/n-3 ratio was defined as total omega-6 divided by total omega-3 PUFAs. The AA/EPA ratio and n-3 index (EPA + DHA as a percentage of total fatty acids) were also calculated. Plasma cytokines (IL-4, IL-6, IL-10, IL-12p70, IL-17, IFN-γ, and TNF-α) were measured by Luminex multiplex assay. Nutritional assessment included body weight, BMI, white blood cell count, total cholesterol, triglycerides, HDL, LDL, serum albumin, prealbumin, NRS 2002, and PG-SGA.
Data management and statistical analysis. Paper case report forms were double-checked, and two researchers independently entered data into an electronic database, followed by consistency verification and logical validation. A random 20% sample of key indicators was re-tested, and the intraclass correlation coefficient was computed for consistency. For variables with >5% missing data, multiple imputation using chained equations was applied. Statistical analyses were conducted using SPSS version 26.0. Categorical variables are presented as frequencies and percentages. Normally distributed continuous variables are presented as mean ± standard deviation, and non-normally distributed variables as median with interquartile range. Baseline comparisons used chi-square or Fisher's exact test and independent-samples t-test or Mann-Whitney U test. Longitudinal changes were evaluated by repeated-measures analysis of variance, with Greenhouse-Geisser correction when sphericity was violated. Trends in ordinal categorical variables were assessed using Cochran-Armitage and Cochran-Mantel-Haenszel tests. Spearman's rank correlation was used to examine associations between fatty acid parameters and toxicity severity. Univariate logistic regression and receiver operating characteristic (ROC) curve analysis were used to evaluate predictive performance, with the optimal cutoff determined by Youden's index. Calibration was assessed by the Hosmer-Lemeshow test. Because only 22 grade ≥3 RIOM events occurred, multivariable adjustment and internal validation were not performed to avoid overfitting, and predictive performance should be regarded as exploratory.
Sample size and limitations. A total of 105 patients with LA-NPC and 105 healthy controls were enrolled. All patients completed the protocol without loss to follow-up. This single-center, single-arm study in a homogeneous Chinese population may limit generalizability, and the non-randomized design precludes causal inference. The small number of grade ≥3 RIOM events led to wide confidence intervals and precluded extensive multivariable adjustment. No internal or external validation was performed; therefore, the predictive performance should be considered exploratory. Dietary records and dosimetric parameters were not collected. Residual confounding cannot be excluded.
683 studies on the registry are indexed under Nasopharyngeal Carcinoma; 270 are open to participants now.
This study's enrollment of 210 is above the median of 100 across 557 interventional studies indexed under Nasopharyngeal Carcinoma.
Browse Nasopharyngeal Carcinoma studies →Affiliated Hospital of Guangdong Medical University is the lead sponsor of 12 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients:
Healthy controls:
Exclusion Criteria:
Patients:
Healthy controls:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received protocol-directed three-stage treatment. Stage 1 was induction chemoimmunotherapy with intravenous toripalimab 240 mg, cisplatin 80 mg/m², and nab-paclitaxel 260 mg/m² on day 1 of each 21-day cycle for 3 cycles. Stage 2 was concurrent toripalimab 240 mg every 21 days plus intensity-modulated radiotherapy (IMRT) without concurrent cisplatin. Stage 3 was adjuvant toripalimab 240 mg every 3 weeks for 6 cycles. IMRT target doses were GTVnx/GTVnd 69.96 Gy, CTV1 60 Gy, and CTV2 54 Gy in 33 fractions, once daily, 5 days per week. Blood samples were collected at prespecified time points for erythrocyte fatty acid, cytokine, and nutritional assessments.
Biological: Toripalimab (240mg day1, Q3W*3cycle) · Drug: Cisplatin (80 mg/m2) · Drug: Nab-paclitaxel · Radiation: Intensity-Modulated Radiotherapy (IMRT)
PD-1 inhibitor given intravenously at 240 mg on day 1 of each 21-day cycle. It was administered during induction chemoimmunotherapy for 3 cycles, concurrently with radiotherapy for 3 cycles, and as adjuvant therapy for 6 cycles.
Drug page: Cisplatin
Platinum-based chemotherapy given intravenously at 80 mg/m² on day 1 of each 21-day cycle during induction chemoimmunotherapy for 3 cycles. It was not given concurrently with radiotherapy.
Taxane chemotherapy given intravenously at 260 mg/m² on day 1 of each 21-day cycle during induction chemoimmunotherapy for 3 cycles.
External beam radiotherapy delivered with intensity modulation. Target doses were GTVnx and GTVnd 69.96 Gy, CTV1 60 Gy, and CTV2 54 Gy in 33 fractions, once daily, 5 days per week. It was given concurrently with toripalimab and without concurrent cisplatin.
Longitudinal change in erythrocyte membrane n-6/n-3 fatty acid ratio.
Change in erythrocyte membrane n-6/n-3 polyunsaturated fatty acid (PUFA) ratio from baseline to 1 month after radiotherapy.
Time frame: Baseline (within 1 week before treatment) to 1 month after radiotherapy (T7).
Longitudinal change in erythrocyte membrane ALA level.
Change in erythrocyte membrane alpha-linolenic acid (ALA) level from baseline to 1 month after radiotherapy.
Time frame: Baseline (within 1 week before treatment) to 1 month after radiotherapy (T7).
Longitudinal change in erythrocyte membrane EPA level.
Change in erythrocyte membrane eicosapentaenoic acid (EPA) level from baseline to 1 month after radiotherapy.
Time frame: Baseline (within 1 week before treatment) to 1 month after radiotherapy (T7).
Longitudinal change in erythrocyte membrane DHA level.
Change in erythrocyte membrane docosahexaenoic acid (DHA) level from baseline to 1 month after radiotherapy.
Time frame: Baseline (within 1 week before treatment) to 1 month after radiotherapy (T7).
Longitudinal change in erythrocyte membrane LA level.
Change in erythrocyte membrane linolenic acid (LA) level from baseline to 1 month after radiotherapy.
Time frame: Baseline (within 1 week before treatment) to 1 month after radiotherapy (T7).
Longitudinal change in erythrocyte membrane AA level.
Change in erythrocyte membrane arachidonic acid (AA) level from baseline to 1 month after radiotherapy.
Time frame: Baseline (within 1 week before treatment) to 1 month after radiotherapy (T7).
Longitudinal change in erythrocyte membrane DTA level.
Change in erythrocyte membrane docosatetraenoic acid (DTA) level from baseline to 1 month after radiotherapy.
Time frame: Baseline (within 1 week before treatment) to 1 month after radiotherapy (T7).
Dynamic Changes in IL-4
Changes in plasma levels of interleukin-4 (IL-4) during treatment.
Time frame: Baseline (T0) to 1 month after radiotherapy (T7).
Dynamic Changes in IL-6
Changes in plasma levels of interleukin-6 (IL-6) during treatment.
Time frame: Baseline (T0) to 1 month after radiotherapy (T7).
Dynamic Changes in IL-10
Changes in plasma levels of interleukin-10 (IL-10) during treatment.
Time frame: Baseline (T0) to 1 month after radiotherapy (T7).
Dynamic Changes in IL-12p70
Changes in plasma levels of interleukin-12p70 (IL-12p70) during treatment.
Time frame: Baseline (T0) to 1 month after radiotherapy (T7).
Dynamic Changes in IL-17
Changes in plasma levels of interleukin-17 (IL-17) during treatment.
Time frame: Baseline (T0) to 1 month after radiotherapy (T7).
Dynamic Changes in IFN-γ
Changes in plasma levels of interferon-gamma (IFN-γ) during treatment.
Time frame: Baseline (T0) to 1 month after radiotherapy (T7).
Dynamic Changes in TNF-α
Changes in plasma levels of tumor necrosis factor-alpha (TNF-α) during treatment.
Time frame: Baseline (T0) to 1 month after radiotherapy (T7).
Incidence, Severity, and Timing of Treatment-Related Adverse Events
Incidence, severity (CTCAE v5.0), and timing of all treatment-related adverse events, with particular attention to radiation-induced oral mucositis (RIOM).
Time frame: From start of treatment to 1 month after radiotherapy (T7).
Correlation Between Severe RIOM and Erythrocyte Fatty Acid Profile or Cytokine Levels
Correlation between grade ≥3 radiation-induced oral mucositis and erythrocyte membrane fatty acid parameters or plasma cytokine levels at key time points.
Time frame: Pre-radiotherapy (T4) and mid-radiotherapy (T5, 40 Gy).
Dynamic Changes in Body Weight
Changes in body weight (kg) during treatment.
Time frame: Baseline (T0) to 1 month after radiotherapy (T7).
Dynamic changes in Patient-Generated Subjective Global Assessment (PG-SGA) classification
Change in nutritional status classification assessed by the Patient-Generated Subjective Global Assessment (PG-SGA) from baseline to 1 month after radiotherapy. Nutritional status is classified into three categories: Stage A (well-nourished), Stage B (moderate or suspected malnutrition), and Stage C (severe malnutrition).
Time frame: Baseline (T0) to 1 month after radiotherapy (T7).
Predictive Value of Pre-Radiotherapy n-6/n-3 Ratio for Grade ≥3 RIOM
Predictive performance of pre-radiotherapy erythrocyte membrane n-6/n-3 fatty acid ratio for grade ≥3 radiation-induced oral mucositis, including odds ratio, area under the ROC curve, sensitivity, specificity, and negative predictive value.
Time frame: From the pre-radiotherapy assessment (T4) until the first documented occurrence of grade ≥3 RIOM or completion of the 1-month post-radiotherapy follow-up (T7), whichever came first, assessed up to a maximum of 12 weeks.
Dynamic Changes in BMI
Changes in body mass index (BMI, kg/m²) during treatment.
Time frame: Baseline (T0) to 1 month after radiotherapy (T7).
Dynamic Changes in serum albumin level
Changes in serum albumin during treatment.
Time frame: Baseline (T0) to 1 month after radiotherapy (T7).
Dynamic Changes in total cholesterol level
Change in total cholesterol level from baseline to 1 month after radiotherapy.
Time frame: Baseline (T0) to 1 month after radiotherapy (T7).
Dynamic Changes in triglyceride level
Change in triglyceride level from baseline to 1 month after radiotherapy.
Time frame: Baseline (T0) to 1 month after radiotherapy (T7).
Dynamic Changes in low-density lipoprotein cholesterol (LDL-C) level
Change in low-density lipoprotein cholesterol (LDL-C) level from baseline to 1 month after radiotherapy.
Time frame: Baseline (T0) to 1 month after radiotherapy (T7).
Dynamic Changes in high-density lipoprotein cholesterol (HDL-C) level
Change in high-density lipoprotein cholesterol (HDL-C) level from baseline to 1 month after radiotherapy.
Time frame: Baseline (T0) to 1 month after radiotherapy (T7).
Plan to share: Yes — De-identified individual participant data underlying the published results will be made available from the corresponding author upon reasonable request. Data include demographic and clinical characteristics, treatment details, erythrocyte membrane fatty acid profiles, plasma cytokine levels, nutritional parameters, and adverse event data. Requests should be directed to the corresponding author (Haiqing Luo, hqluo@126.com).
Supporting information: Study protocol, Statistical analysis plan
Time frame: Individual participant data will be available upon reasonable request after publication of the study results. No fixed end date.
Access criteria: Access will be granted to researchers who contact the corresponding author (Haiqing Luo, hqluo@126.com) with a methodologically sound research proposal and obtain approval from the institutional ethics committee of the Affiliated Hospital of Guangdong Medical University. A data sharing agreement may be required. De-identified data will be shared for research purposes only.
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Studies of the drugs tested here: Toripalimab · Cisplatin · Albumin-Bound Paclitaxel
Affiliated Hospital of Guangdong Medical University