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Active, not recruitingNCT05576272Updated Nov 22, 2023

A Phase II/III Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Nasopharyngeal Carcinoma

A Phase 2/3 interventional study of QL1706 and Carrelizumab in Nasopharyngeal Carcinoma, sponsored by Qilu Pharmaceutical Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as active, not recruiting.
  • Registered 4 months after the study started (first participant enrolled May 2022, registered Sep 2022).
Phase
Phase 2/3
Study type
Interventional
Enrollment
460
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a randomized, open, multicenter phase II/III trial to compare the efficacy and safety of QL1706 and carrilizumab combined with gemcitabine and cisplatin in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

Read the detailed description

This is a randomized, open, multicenter phase II/III trial to compare the efficacy and safety of QL1706 and carrilizumab combined with gemcitabine and cisplatin in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma. The study is divided into two parts.

The first part is a phase II, single-arm study with an introductory safety phase, which is planned to enroll 30 subjects with nasopharyngeal carcinoma treated with first-line QL1706 in combination with gemcitabine and cisplatin. The primary objective of the first part is to evaluate the safety and tolerability of QL1706 combined with gemcitabine and cisplatin in the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma.

The second part is a phase III randomized, controlled study. The study plans to enroll 430 subjects, who will be randomized in a 1:1 ratio to a trial group of QL1706 in combination with gemcitabine and cisplatin and a control group of carrilizumab in combination with gemcitabine and cisplatin. The primary objective of the second part was to compare the effectiveness of QL1706 with that of carrilizumab combined with gemcitabine and cisplatin, respectively, in the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

02

Conditions studied

  • Nasopharyngeal Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 460 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The subject will participate voluntarily and sign the informed consent form.
  2. Age ≥ 18 years when signing the informed consent form, male or female.
  3. The Eastern Collaborative Oncology Group (ECOG) physical status score was 0 or 1.
  4. Expected survival ≥ 3 months.
  5. Patients with pathologically confirmed nasopharyngeal carcinoma.
  6. Patients with primary diagnosis of metastatic nasopharyngeal carcinoma [stage IVb according to the American Joint Committee on Cancer AJCC staging system (8th edition)] or patients with recurrent (including recurrent or metastatic) nasopharyngeal carcinoma who are not candidates for radical surgery or radiotherapy or other local treatment; and for recurrent or metastatic lesions must be untreated systemically: previously treated with neoadjuvant chemotherapy with curative intent, Patients with adjuvant chemotherapy, radiotherapy or radiotherapy must have had ≥ 6 months between the last chemotherapy and or radiotherapy and the time of disease recurrence and/or development of metastases.
  7. Patients have at least one imaging measurable lesion according to RECISTv1.1 evaluation criteria; for lesions that have received prior radiotherapy or other local treatment there must be evidence of definite progression of the lesion after the end of local treatment in order to be selected as a measurable lesion.
  8. Adequate organ function prior to first use of the experimental drug (no blood components, leukocyte-raising drugs, or platelet-raising drugs are allowed within 7 days prior to obtaining laboratory tests)

    1. Absolute neutrophil count ≥ 1.5 x 109/L.
    2. Platelet count ≥ 100×109/L.
    3. Hemoglobin ≥ 90 g/L.
    4. Serum albumin ≥ 28 g/L.
  9. Subjects (both female and male) agree to use effective contraception from the time they sign the informed consent until 180 days after the last use of the trial drug. Women who are not pregnant or breastfeeding from the time they sign informed consent until 180 days after the last use of the trial drug.

Exclusion criteria

Exclusion Criteria:

  1. Presence of symptomatic central nervous system (CNS) metastases, soft meningeal metastases, or spinal cord compression due to metastases.
  2. Prior systemic anticancer treatment with approved drugs or trial drugs.
  3. End date of palliative radiotherapy targeting bone metastases or soft tissue, etc. ≤ 7 days from imaging of baseline tumor lesions
  4. Presence of carcinomatous meningitis prior to first study treatment
  5. Active autoimmune disease present within 2 years prior to the first administration of the investigational drug and requiring systemic systemic therapy. Subjects with relevant alternative therapy who are stable are allowed to be included.
  6. Disease requiring systemic treatment with corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive drugs present within 2 weeks prior to first study treatment.
  7. At the investigator's discretion, have a serious concomitant condition that jeopardizes patient safety, or interferes with patient completion of the study, such as hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) not controlled by two or more antihypertensive medications, or severe diabetes mellitus.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
460 participants (estimated)

Study arms

  • Experimental
    QL1706 Combined with Gemcitabine and Cisplatin

    Drug: QL1706 · Drug: Gemcitabine · Drug: Cisplatin

  • Active comparator
    Carrilizumab Combined with Gemcitabine and Cisplatin

    Drug: Carrelizumab · Drug: Gemcitabine · Drug: Cisplatin

Interventions

  • DrugQL1706

    5 mg/kg#D1#Q3W IV, 4-6 cycles

  • DrugCarrelizumab

    200mg#D1#Q3W IV, 4-6 cycles

  • DrugGemcitabine

    1000mg/m2#D1\&D8#Q3W IV, 4-6 cycles

  • DrugCisplatin

    80mg/m2#D1#Q3W IV, 4-6 cycles

06

What researchers measure

Primary outcomes

  1. Progression free survival (PFS) -BICR

    The PFS assessed by Blinded independent central review (BICR)

    Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered

Secondary outcomes

  1. PFS- Investigator

    The PFS assessed by Investigator

    Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered

  2. Objective remission rate (ORR)

    The ORR assessed by BICR and Investigator

    Time frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 72 weeks

  3. Duration of remission (DOR)

    The DOR assessed by BICR and Investigator

    Time frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 72 weeks

  4. Disease Control Rate (DCR)

    The DCR assessed by BICR and Investigator

    Time frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 72 weeks

  5. Overall survival (OS)

    Overall survival

    Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered

  6. 12-month OS rate

    12-month Overall survival rate

    Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered

07

Study locations

1 site
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangzhou 510060, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05576272
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Oct 12, 2022
Start date
May 19, 2022
Primary completion
Dec 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Nov 22, 2023

Study contacts

li Zhang, Doctor
principal investigator · Sun Yat-sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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