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Head and Neck Squamous Cell CarcinomaPhase 3NCT04146402

SCT-I10A Plus Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma

A Phase 3 study testing SCT-I10A+chemo in people with Head and Neck Squamous Cell Carcinoma, run by Sinocelltech Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this study is to evaluate the efficacy and safety of SCT-I10A plus standard chemotherapy for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
SCT-I10A+chemo
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
330 participants
Where
1 siteChina
Study dates
31 Dec 2019to 30 Jul 2022
Phase
Phase 3
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in this clinical trial and sign an informed consent form;
  • Male or female, age ≥ 18 years old;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Has histologically- or cytologically-confirmed recurrent or metastatic (disseminated) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx;
  • Is considered incurable by local therapies;
  • Have measurable disease based on RECIST1.1. tumor lesions, situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesion after 3 months of radiotherapy;
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  • Have provided tissue for PD-L1 biomarker analysis
  • The estimated survival period is ≥ 3 months;
  • Laboratory inspection:
  • Blood routine: neutrophils ≥1.5×l09/L, platelets≥75×109/L, hemoglobin≥80g/L; Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST ≤ upper limit of normal value × 3 for liver metastasis, ALT and AST ≤ upper limit of normal value for liver metastases × 5; total bilirubin ( TBIL) ≤ upper limit of normal value × 1.5; Renal function: creatinine (Cr) ≤ normal upper limit × 1.5; Coagulation: Activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), Prothrombin Time (PT) ≤1.5xULN Echocardiogram: LVEF≥50%
  • Subjects should agree to use an adequate method of contraception starting with the first dose of study medication through 6 months after the last dose of study therapy. Female subjects of childbearing potential should have a negative blood pregnancy test within 7 days prior to receiving the first dose of study medication, and should be non-breastfeeding;

Who cannot join

  • Disease is suitable for local therapy administered with curative intent
  • Has received systemic chemotherapy, except being part of the multimodality treatment for local advanced HNSCC (the chemotherapy should be ended≥6 months prior to first dose of study treatment)
  • Has progressed within 6 months after multimodality treatment for local advanced HNSCC
  • Prior therapy with an anti-PD-1 or anti-PD1-L1 or -L2 therapy, or anti-CD137, or anti-CTLA-4 therapy
  • Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical cancers;
  • Has received cetuximab within 6 months prior to first dose of study treatment
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  • NCI CTCAE v5.0 Grading of Peripheral Neuropathy≥2;
  • Active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previous treated brain metastases may participate provided they are stable for at least 2 weeks prior to the first dose of study medication, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment. Subjects with asymptomatic BM (without neurological symptoms, not using steroids, tumor lesions≤1.5cm) may participate in condition that the tumor lesion should be regularly evaluated using identical imaging modality for each assessment, either MRI or CT scans;
  • At the time of enrollment, patients still had ≥2 toxic side effects (except for hair loss, hearing loss, tinnitus, dry mouth or platinum-induced grade 2 neurotoxicity) caused by previous anti-tumor treatment;
  • Has known serious allergic reaction to study medication or any component of the product, and has known serious allergic reaction to other monoclonal antibodies (NCI CTCAE v5.0≥3);
  • Has received anti-tumor therapy, including chemotherapy, hormonal therapy, immunotherapy, radiotherapy, and etc. within 4 weeks of the first dose of treatment, except palliative radiotherapy for bone pain;
  • Has received any Chinese traditional medicine for anti-cancer purpose within 1 week of the first dose of treatment;
  • Has undergone important surgery within 4 weeks prior to first dose of treatment or has scheduled an important surgery during the study;
  • Has received immunosuppressive drugs during the study or within 2 weeks prior to first dose of treatment, except for the following situations:
  • Intranasal, inhaled, topical corticosteroids (e.g. intra-articular injections); Physiological dose for systemic prednisolone (≤10mg/d or equivalent); Short-term administration (≤7days) of corticosteroids for prophylaxis or treatment against non-autoimmune allergic disease
  • Has known active, and/ or history of autoimmune disease (systemic lupus erythematous, rheumatoid arthritis, inflammatory bowel disease, AITD, multiple sclerosis, vasculitis, glomerulonephritis), and is likely to get a recurrence, or is at high-risk (organ-transplanted patients need immunotherapy), except those with stable type 1 DM after fixed dose of insulin administration , or those with autoimmune hypothyroidism only require HRT, or those with skin disorders that does not require systemic treatment (e.g. eczema, rash <10% BSA, psoriasis without symptoms around eyes)
  • Has known interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, except asymptomatic drug-induced pneumonitis or radiation pneumonitis
  • Has a known history of HIV
  • Has known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C(e.g. HCV RNA [quantitative] is detected)
  • has uncontrolled active infections within 2 weeks before enrollment
  • Has received a live vaccine within 4 weeks prior to first dose of study treatment, except
  • Is with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);
  • Has severe conditions, including NYHA III heart failure, IHD, history of MI within 3 months prior to first dose of study treatment, poorly controlled DM (FBS≥10mmol/L) or poorly controlled hypertension (SBP≥160mmHg and/ or DBP≥100mmHg)
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Is currently participating in other clinical trials, or has participated in a study of an investigational agent and received study therapy, or used an investigational device, any of whose end date is within 4 weeks prior to the first dose of study medication
  • has alcohol or drug addiction;
  • Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator，such as inability to comply with study and/or follow-up procedures.

Trial locations and contacts

1 site in 1 country.

Yan Wang, MD contact

15201286305

SCT-CT@sinocelltech.com

China1 site, 1 recruiting

  • The Third Affiliated Hospital Of Qiqihar Medical University

    Qiqihar

    Zhongling Xu, MD, 15845688067, xuzhongling2009@126.com

    Recruiting

Other trials in China

About this study

Official title: SCT-I10A Combined With Standard Chemotherapy Versus Placebo Combined With Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC): A Phase III, Multicenter, Randomized, Double-blinded Trial

The objective of this study is to evaluate the efficacy and safety of SCT-I10A plus standard chemotherapy for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma

Read the detailed description

This is a Phase III, multicenter, randomized, double-blinded trial designed to evaluate Overall survival (OS) of SCT-I10A combined with standard chemotherapy in patients living with Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma

Being tested
SCT-I10A+chemo, Placebos+chemo
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • SCT-I10A+chemoDrug

    Also called SCT-I10A

    SCT-I10A, 200 mg intravenous (IV) on Day 1 of each 3-week cycle Standard chemotherapy: Cisplatin+5-FU

  • Placebos+chemoDrug

    Also called Placebo

    Placebo, 200 mg intravenous (IV) on Day 1 of each 3-week cycle Standard chemotherapy: Cisplatin+5-FU

Study groups in NCT04146402
Study groupRoleWhat they receive
SCT-I10A + ChemotherapyExperimentalSCT-I10A, 200 mg intravenous (IV) on Day 1 of each 3-week cycle. Chemotherapy: cisplatin+5-FU
Receives: Drug: SCT-I10A+chemo
Placebo + ChemotherapyActive comparatorPlacebo, 200 mg intravenous (IV) on Day 1 of each 3-week cycle. Chemotherapy: cisplatin+5-FU
Receives: Drug: Placebos+chemo

What is being measured

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

  1. Overall survival

    OS is defined as time from first dose of SCT-I10A until the date of death from any cause

    Measured: 1 year

Secondary outcomes (2)

  1. Progression free survival

    PFS is defined as the time from first dose of SCT-I10A until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criter

    Measured: 1 year

  2. Objective response rate

    ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment

    Measured: 1 year

Timeline

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

  1. First posted31 Oct 2019
  2. Study start31 Dec 2019
  3. Primary completion29 Jan 2022 (estimated)
  4. Study completion30 Jul 2022 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04146402
Sponsor's protocol ID
SCT-I10A-B301
Status last verified
Feb 2020
First submitted
29 Oct 2019
Last updated
5 Feb 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shi Y, Guo W, Wang W, Wu Y, Fang M, Huang X, Han P, Zhang Q, Dong P, Zhou X, Peng H, Hu C, Chen X, Zhang S, Chang Z, Li X, Ding Y, Qu S, Jing S, Zhang S, Gui L, Sun Y, Wang L, Liu Y, Wu H, Li G, Fu Z, Shi J, Jiang H, Bai Y, Cui J, Zheng Y, Cui W, Jia X, Zhai L, Cai Q, Xiong D, Wu Y, Cao J, Wu R, Hu G, Peng L, Xie L, Gai W, Wang Y, Su Y. Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial. Nat Med. 2024 Sep;30(9):2568-2575. doi: 10.1038/s41591-024-03110-7. Epub 2024 Jun 28.

    PubMed 38942993

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SCT-I10A+chemo in people with Head and Neck Squamous Cell Carcinoma, run by Sinocelltech Ltd. at 1 site 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 11 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Yan Wang, MD (15201286305, SCT-CT@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 1 year). 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 NCT04146402, which also lists 1 linked publication.

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 5 Feb 2020.

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