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Nasopharyngeal Cancinoma (NPC)Phase 2LIGHTNCT07325539

LDRT Combined With Toripalimab and Chemotherapy for Recurrent/Metastatic NPC

A Phase 2 study testing Gemcitabine(GEM), Cisplatin and Toripalimab in people with Nasopharyngeal Cancinoma (NPC) and Nasopharangeal Cancer, run by Sun Yat-sen University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to evaluate the efficacy and safety of LDRT combined with toripalimab and GP chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma through a prospective, open-label, single-arm Phase II clinical trial. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Gemcitabine(GEM), Cisplatin and Toripalimab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
2 sitesChina
Study dates
12 Jan 2026to 30 Jan 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-65 years old.
  • Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II or III).
  • ECOG Performance Status score of 0-1.
  • At least one measurable lesion as per RECIST v1.1 criteria.
  • Patients with newly diagnosed metastatic NPC, or patients with locoregionally advanced NPC who developed metastasis ≥6 months or recurrence ≥12 months after completing radical radiotherapy/chemotherapy for the primary lesion.
  • No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent/metastatic lesions.
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  • Adequate organ function, meeting the following criteria within 7 days prior to treatment:
  • Hematological criteria (without transfusion or hematopoietic growth factor support within 14 days):
  • Hemoglobin (Hb) ≥90 g/L.
  • White Blood Cell (WBC) count ≥4.0 × 10⁹/L.
  • Platelet count (PLT) ≥100 × 10⁹/L.
  • Biochemical criteria:
  • Total Bilirubin (TBIL) ≤1.5 × Upper Limit of Normal (ULN).
  • Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5 × ULN.
  • Serum Creatinine (Cr) ≤1.5 × ULN AND Creatinine Clearance (CCr) ≥60 mL/min.
  • Coagulation function: INR and APTT ≤1.5 × ULN.
  • Normal results for myocardial injury markers, heart failure markers, and electrocardiogram (ECG). For patients with abnormal results in any of these, the investigator will assess the need for Doppler echocardiography.
  • Thyroid function: TSH ≤ ULN. If abnormal, FT3 and FT4 levels should be considered; patients can be enrolled if FT3 and FT4 levels are normal.
  • Women of childbearing potential must have used reliable contraception, have a negative serum pregnancy test within 7 days before enrollment, and be willing to use adequate contraception during the trial and for 8 weeks after the last dose of the study drug, or be surgically sterile. Men must agree to use adequate contraception or be surgically sterile during the trial and for 8 weeks after the last dose.
  • Voluntary provision of signed informed consent, with good compliance.

Who cannot join

  • Disease progression within 6 months after completing standard treatment for locoregionally advanced nasopharyngeal carcinoma.
  • Absence of identifiable tumor lesions in both the primary site and locoregional lymph nodes, precluding the development of an LDRT plan.
  • Inability to undergo MRI due to reasons such as implanted metal devices or claustrophobia.
  • Requirement for systemic use of corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose or during the study. Inhaled or topical steroids and adrenal replacement steroid doses >10 mg/day prednisone equivalent are permitted in the absence of active autoimmune disease. Physiological replacement doses of corticosteroids (≤10 mg/day prednisone equivalent) are allowed.
  • Recurrent target lesions suitable for curative surgery or a second course of radiotherapy.
  • History of any active autoimmune or autoimmune disease, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. Exceptions include type I diabetes, hypothyroidism requiring hormone replacement therapy, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
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  • Active or uncontrolled severe infection (≥CTCAE Grade 3) within 4 weeks prior to enrollment.
  • History of active tuberculosis within the past year, regardless of treatment. Patients with a history of active pulmonary tuberculosis over 1 year ago who have documented evidence of adequate past anti-tuberculosis treatment may be considered; otherwise, they are excluded.
  • History of hypertension that cannot be adequately controlled with a single antihypertensive medication (systolic BP ≥150 mmHg or diastolic BP ≥90 mmHg).
  • Clinically significant bleeding symptoms or definite bleeding tendency, specifically excluding cases of local recurrence with high bleeding risk or cases within 1 year post-radiotherapy assessed to have a high risk of necrosis.
  • Urinalysis showing urine protein ≥ ++ AND confirmed 24-hour urine protein ≥1.0 g.
  • Myocardial ischemia (above Grade I), myocardial infarction, arrhythmia (including QTc ≥480 ms), or ≥ Grade 2 congestive heart failure (NYHA classification) within 6 months prior to enrollment.
  • If an echocardiogram is required per Inclusion Criterion 7(4), results showing Left Ventricular Ejection Fraction (LVEF) below the lower limit of normal (60%).
  • Diagnosis of other malignancies within 5 years prior to enrollment, except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.
  • Presence of leptomeningeal or central nervous system metastases.
  • HIV positive, TP positive, liver cirrhosis, decompensated liver disease, active hepatitis (uncontrolled active hepatitis despite treatment: Hepatitis B - HBsAg positive and HBV DNA ≥1 × 10⁴ copies/mL; Hepatitis C - HCV RNA positive with abnormal liver function; co-infection with HBV and HCV) requiring antiviral therapy.
  • Participation in another anti-tumor drug clinical trial within 4 weeks prior to enrollment.
  • Administration of any live attenuated vaccine within 30 days prior to enrollment.
  • Contraindications to radiotherapy.
  • Known allergy to the study drug or any of its excipients, or history of severe allergic reactions to other monoclonal antibodies.
  • History of psychoactive drug abuse unable to be abstained, or presence of psychiatric disorders.
  • Any other condition assessed by the investigator as potentially endangering the patient's safety or compliance, including severe concurrent diseases (including psychiatric disorders) requiring prompt treatment, severely abnormal laboratory test results, or other psychological, familial, or sociological factors deemed high-risk.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jun Ma, M.D. contact

+862087343469

majun2@mail.sysu.edu.cn

Zhe Li, Ph.D. contact

+862087342370

lizhe2@sysucc.org.cn

China2 sites, 2 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

    Jun Ma, vice president, +862087343469, majun2@mail.sysu.edu.cn

    Jun Ma, Professor

    Recruiting

  • Cancer Hospital and Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Shenzhen, Guangdong, 518116

    Yan-Ling Wu, 0755-66618168, wuyl1202@163.com

    Recruiting

Other trials in China

About this study

Official title: Low-dose Radiotherapy (LDRT) Combined With Toripalimab and GP Chemotherapy for Recurrent/Metastatic Nasopharyngeal Carcinoma (LIGHT): A Multicentre, Open-Label, Single-Arm Phase II Clinical Study

This study aims to evaluate the efficacy and safety of LDRT combined with toripalimab and GP chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma through a prospective, open-label, single-arm Phase II clinical trial.

Being tested
Gemcitabine(GEM), Cisplatin, Toripalimab, LDRT
Keywords
PD-1 antibody, Low dose radiotherapy, Recurrent/Metastatic Nasopharyngeal Carcinoma
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gemcitabine(GEM)Drug

    Gemcitabine 1000mg/m2, d1 \& 8 of every cycle, every 3 weeks for 4-6 cycles

  • CisplatinDrug

    Cisplatin 80mg/m2, d1 of every cycle, every 3 weeks for 4-6 cycles

  • ToripalimabDrug

    Toripalimab 240 mg, d1of every cycle, every 3 weeks for 4-6 cycles. Toripalimab maintenance, 240 mg, d1of every cycle, every 3 weeks until disease progression or unacceptable toxicity.

  • LDRTRadiation

    Irradiation of the primary lesion and regional metastatic lymph nodes, 0.5 Gy per fraction for 4 fractions, d0-3, every 3 weeks for 4-6 cycles

Study groups in NCT07325539
Study groupRoleWhat they receive
LDRT + Toripalimab + GP chemotherapyExperimentalPatients will receive LDRT plus toripalimab and GP chemotherapy for 4-6 cycles, then followed by toripalimab until disease progression or unacceptable toxicity.
Receives: Drug: Gemcitabine(GEM); Drug: Cisplatin; Drug: Toripalimab; Radiation: LDRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) assessed by RECIST 1.1

    PFS was defined as the time from enrollment to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: up to approximately 2 years

Secondary outcomes (4)

  1. Objective Response Rate（ORR）

    The proportion of patients who achieved a complete response (CR) or partial response (PR), assessed according to RECIST v1.1.

    Measured: up to approximately 2 years

  2. Progression-free survival (PFS) assessed by iRECIST

    PFS was defined as the time from enrollment to the first occurrence of disease progression as determined according to iRECIST or death from any cause, whichever occurs first.

    Measured: up to approximately 2 years

  3. Overall survival (OS)

    OS was defined as the time from enrollment to death from any cause.

    Measured: up to approximately 4 years

  4. Adverse events

    All adverse event or serious adverse event that occurred during the study period according to CTCAE V5.0.

    Measured: up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study start12 Jan 2026
  3. Primary completion30 Jan 2028 (estimated)
  4. Study completion30 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07325539
Sponsor's protocol ID
2025-FXY-451-FLK
Acronym
LIGHT
Status last verified
May 2026
First submitted
24 Dec 2025
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee N, Harris J, Garden AS, Straube W, Glisson B, Xia P, Bosch W, Morrison WH, Quivey J, Thorstad W, Jones C, Ang KK. Intensity-modulated radiation therapy with or without chemotherapy for nasopharyngeal carcinoma: radiation therapy oncology group phase II trial 0225. J Clin Oncol. 2009 Aug 1;27(22):3684-90. doi: 10.1200/JCO.2008.19.9109. Epub 2009 Jun 29.

    PubMed 19564532

  • Lee NY, Zhang Q, Pfister DG, Kim J, Garden AS, Mechalakos J, Hu K, Le QT, Colevas AD, Glisson BS, Chan AT, Ang KK. Addition of bevacizumab to standard chemoradiation for locoregionally advanced nasopharyngeal carcinoma (RTOG 0615): a phase 2 multi-institutional trial. Lancet Oncol. 2012 Feb;13(2):172-80. doi: 10.1016/S1470-2045(11)70303-5. Epub 2011 Dec 15.

    PubMed 22178121

  • Liu Z, Wang D, Li G, Yi M, Zhang Z, Zhong G, Xu L, Jiang R, Zheng Y, Huang L, Peng Y, Liang L, Li J, Liu Y, Lai J, Lv X, Xu Y, Liu Q, Wang Z, Liu Z, Yang Q, Nie L, Lei J, Huang X, Liu Z, Jiang W. Neoadjuvant with low-dose radiotherapy, tislelizumab, albumin-bound paclitaxel, and cisplatin for resectable locally advanced head and neck squamous cell carcinoma: phase II single-arm trial. Nat Commun. 2025 May 17;16(1):4608. doi: 10.1038/s41467-025-59865-1.

    PubMed 40382318

  • Wang H, Yao Z, Kang K, Zhou L, Xiu W, Sun J, Xie C, Yu M, Li Y, Zhang Y, Zheng Y, Lin G, Pan X, Wu Y, Luo R, Wang L, Tang M, Liao S, Zhu J, Zhou X, Zhang X, Xu Y, Liu Y, Peng F, Wang J, Xiang L, Yin L, Deng L, Huang M, Gong Y, Zou B, Wang H, Wu L, Yuan Z, Bi N, Fan M, Xu Y, Tong R, Yi L, Gan L, Xue J, Mo X, Chen C, Na F, Lu Y. Preclinical study and phase II trial of adapting low-dose radiotherapy to immunotherapy in small cell lung cancer. Med. 2024 Oct 11;5(10):1237-1254.e9. doi: 10.1016/j.medj.2024.06.002. Epub 2024 Jul 3.

    PubMed 38964333

  • Li S, Li K, Wang K, Yu H, Wang X, Shi M, Liang Z, Yang Z, Hu Y, Li Y, Liu W, Li H, Cheng S, Ye L, Yang Y. Low-dose radiotherapy combined with dual PD-L1 and VEGFA blockade elicits antitumor response in hepatocellular carcinoma mediated by activated intratumoral CD8+ exhausted-like T cells. Nat Commun. 2023 Nov 24;14(1):7709. doi: 10.1038/s41467-023-43462-1.

    PubMed 38001101

  • Chen J, Levy A, Tian AL, Huang X, Cai G, Fidelle M, Rauber C, Ly P, Pizzato E, Sitterle L, Piccinno G, Liu P, Durand S, Mao M, Zhao L, Iebba V, Felchle H, Mallard de La Varende AL, Fischer JC, Thomas S, Greten TF, Jones JC, Monge C, Demaria S, Formenti S, Belluomini L, Dionisi V, Massard C, Blanchard P, Robert C, Quevrin C, Lopes E, Clemenson C, Mondini M, Meziani L, Zhan Y, Zeng C, Cai Q, Morel D, Sun R, Laurent PA, Mangoni M, Di Cataldo V, Arilli C, Trommer M, Wegen S, Neppl S, Riechelmann RP, Camandaroba MP, Neto ES, Fournier PE, Segata N, Holicek P, Galluzzi L, Buque A, Alves Costa Silva C, Derosa L, Kroemer G, Chen C, Zitvogel L, Deutsch E. Low-dose irradiation of the gut improves the efficacy of PD-L1 blockade in metastatic cancer patients. Cancer Cell. 2025 Mar 10;43(3):361-379.e10. doi: 10.1016/j.ccell.2025.02.010.

    PubMed 40068595

  • Herrera FG, Ronet C, Ochoa de Olza M, Barras D, Crespo I, Andreatta M, Corria-Osorio J, Spill A, Benedetti F, Genolet R, Orcurto A, Imbimbo M, Ghisoni E, Navarro Rodrigo B, Berthold DR, Sarivalasis A, Zaman K, Duran R, Dromain C, Prior J, Schaefer N, Bourhis J, Dimopoulou G, Tsourti Z, Messemaker M, Smith T, Warren SE, Foukas P, Rusakiewicz S, Pittet MJ, Zimmermann S, Sempoux C, Dafni U, Harari A, Kandalaft LE, Carmona SJ, Dangaj Laniti D, Irving M, Coukos G. Low-Dose Radiotherapy Reverses Tumor Immune Desertification and Resistance to Immunotherapy. Cancer Discov. 2022 Jan;12(1):108-133. doi: 10.1158/2159-8290.CD-21-0003. Epub 2021 Sep 3.

    PubMed 34479871

  • Zhou L, Liu Y, Wu Y, Yang X, Spring Kong FM, Lu Y, Xue J. Low-dose radiation therapy mobilizes antitumor immunity: New findings and future perspectives. Int J Cancer. 2024 Apr 1;154(7):1143-1157. doi: 10.1002/ijc.34801. Epub 2023 Dec 7.

    PubMed 38059788

  • Herrera FG, Romero P, Coukos G. Lighting up the tumor fire with low-dose irradiation. Trends Immunol. 2022 Mar;43(3):173-179. doi: 10.1016/j.it.2022.01.006. Epub 2022 Jan 31.

    PubMed 35105519

  • Zhang Z, Liu X, Chen D, Yu J. Radiotherapy combined with immunotherapy: the dawn of cancer treatment. Signal Transduct Target Ther. 2022 Jul 29;7(1):258. doi: 10.1038/s41392-022-01102-y.

    PubMed 35906199

  • Yang Y, Pan J, Wang H, Zhao Y, Qu S, Chen N, Chen X, Sun Y, He X, Hu C, Lin L, Yu Q, Wang S, Wang G, Lei F, Wen J, Yang K, Lin Z, Guo Y, Chen S, Huang X, Wu Y, Liang L, Chen C, Bai F, Ma X, Zhang Y, Leaw S, Zhang L, Fang W. Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309). Cancer Cell. 2023 Jun 12;41(6):1061-1072.e4. doi: 10.1016/j.ccell.2023.04.014. Epub 2023 May 18.

    PubMed 37207654

  • Yang Y, Qu S, Li J, Hu C, Xu M, Li W, Zhou T, Shen L, Wu H, Lang J, Hu G, Luo Z, Fu Z, Qu S, Feng W, Chen X, Lin S, Zhang W, Li X, Sun Y, Lin Z, Lin Q, Lei F, Long J, Hong J, Huang X, Zeng L, Wang P, He X, Zhang B, Yang Q, Zhang X, Zou J, Fang W, Zhang L. Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (CAPTAIN-1st): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2021 Aug;22(8):1162-1174. doi: 10.1016/S1470-2045(21)00302-8. Epub 2021 Jun 23.

    PubMed 34174189

  • Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi YR, Jin F, Xu R, Pan J, Qu S, Li P, Hu C, Liu YC, Jiang Y, He X, Wang HM, Lim WT, Liao W, He X, Chen X, Liu Z, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Feng H, Yao S, Keegan P, Xu RH. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nat Med. 2021 Sep;27(9):1536-1543. doi: 10.1038/s41591-021-01444-0. Epub 2021 Aug 2.

    PubMed 34341578

  • Prawira A, Oosting SF, Chen TW, Delos Santos KA, Saluja R, Wang L, Siu LL, Chan KKW, Hansen AR. Systemic therapies for recurrent or metastatic nasopharyngeal carcinoma: a systematic review. Br J Cancer. 2017 Dec 5;117(12):1743-1752. doi: 10.1038/bjc.2017.357. Epub 2017 Oct 24.

    PubMed 29065104

  • Zhang Y, Chen L, Hu GQ, Zhang N, Zhu XD, Yang KY, Jin F, Shi M, Chen YP, Hu WH, Cheng ZB, Wang SY, Tian Y, Wang XC, Sun Y, Li JG, Li WF, Li YH, Tang LL, Mao YP, Zhou GQ, Sun R, Liu X, Guo R, Long GX, Liang SQ, Li L, Huang J, Long JH, Zang J, Liu QD, Zou L, Su QF, Zheng BM, Xiao Y, Guo Y, Han F, Mo HY, Lv JW, Du XJ, Xu C, Liu N, Li YQ, Chua MLK, Xie FY, Sun Y, Ma J. Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma. N Engl J Med. 2019 Sep 19;381(12):1124-1135. doi: 10.1056/NEJMoa1905287. Epub 2019 May 31.

    PubMed 31150573

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine(GEM), Cisplatin and Toripalimab in people with Nasopharyngeal Cancinoma (NPC) and Nasopharangeal Cancer, run by Sun Yat-sen University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jun Ma, M.D. (+862087343469, majun2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) assessed by RECIST 1.1 (time frame: up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07325539, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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