The Efficacy of Induction and Adjuvant Camrelizumab Combined With Chemoradiation for LA-HNSCC

NCT05213884 | Completed Phase 2 DMC

• 1 other identifier: CRIA
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

Brief Summary

This is a phase 2, single-arm clinical trial, with the purpose to evaluate the therapeutic efficacy and safety of PD-1 Blockade camrelizumab combined with induction chemotherapy followed by concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck squamous cell carcinoma.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Camrelizumab; Locally Advanced HNSCC; Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• EFFICACY Progress-free survival (PFS)

  Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.

  2 years

Secondary Outcomes (4)

• EFFICACY Overall survival (OS)

  2 years

• EFFICACY Objective response rate (ORR）

  2 years

• EFFICACY Duration of response (DOR)

  2 years

• SAFETY Incidence rate of adverse events (AEs)

  2 years

Study Arms (1)

Camrelizumab plus chemoradiotherapy

EXPERIMENTAL

Induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. After 4\~6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity.

Drug: Camrelizumab; Drug: Concurrent cisplatin chemotherapy; Radiation: Intensity-modulated radiotherapy (IMRT)

Interventions

Camrelizumab DRUG

200 mg, intravenous infusion over 30 minutes (Q3W); 1\~3 cycles of camrelizumab before radiotherapy and camrelizumab are maintained for 16 cycles (1 year) after the end of radiotherapy.

Also known as: Anti-PD-1 antibody

Camrelizumab plus chemoradiotherapy

Concurrent cisplatin chemotherapy DRUG

cisplatin is given at a dose of 40 mg/m2 via intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy every week for 6 cycles.

Camrelizumab plus chemoradiotherapy

Intensity-modulated radiotherapy (IMRT) RADIATION

70 Gy/ 35 fractions/7 weeks, 5 fractions/week, 1 fraction/day.

Camrelizumab plus chemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥18 years of age.
• ECOG Performance Status 0 or 1.
• Histological diagnosis of squamous cell carcinoma of the lip, oral cavity, oropharynx, hypopharynx, larynx or nasal sinus.
• Stage III, IVa, IVb (according to the 8th AJCC edition); Stage III for HPV positive oropharyngeal disease.
• Inoperable or refused surgery; eligible for definitive concurrent chemoradiotherapy.
• With measurable target lesions by CT or MRI.
• Adequate bone marrow function.
• Adequate renal and liver function.
• Pregnancy test (for patients of childbearing potential) negative at screening.
• Signed Written Informed Consent.

You may not qualify if:

• Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
• Active autoimmune disease (Such as type I diabetes, vitiligo, psoriasis, patients who do not need immunosuppressive drugs do not need to be excluded).
• Has abnormal thyroid function, and the thyroid function cannot be maintained normal despite medical treatment.
• Pregnancy or breast feeding.
• Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
• Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
• Has received a live vaccine within 4 weeks of planned start of study therapy.
• Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Sites (3)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Chongqing University Three Gorges Hospital

Wanzhou, Chongqing Municipality, 404100, China

Location

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

Location

Related Publications (8)

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  PMID: 25154822 BACKGROUND

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  PMID: 27247226 BACKGROUND

• Bauml J, Seiwert TY, Pfister DG, Worden F, Liu SV, Gilbert J, Saba NF, Weiss J, Wirth L, Sukari A, Kang H, Gibson MK, Massarelli E, Powell S, Meister A, Shu X, Cheng JD, Haddad R. Pembrolizumab for Platinum- and Cetuximab-Refractory Head and Neck Cancer: Results From a Single-Arm, Phase II Study. J Clin Oncol. 2017 May 10;35(14):1542-1549. doi: 10.1200/JCO.2016.70.1524. Epub 2017 Mar 22.

  PMID: 28328302 BACKGROUND

• Lee NY, Ferris RL, Psyrri A, Haddad RI, Tahara M, Bourhis J, Harrington K, Chang PM, Lin JC, Razaq MA, Teixeira MM, Lovey J, Chamois J, Rueda A, Hu C, Dunn LA, Dvorkin MV, De Beukelaer S, Pavlov D, Thurm H, Cohen E. Avelumab plus standard-of-care chemoradiotherapy versus chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):450-462. doi: 10.1016/S1470-2045(20)30737-3.

  PMID: 33794205 BACKGROUND

• Uppaluri R, Campbell KM, Egloff AM, Zolkind P, Skidmore ZL, Nussenbaum B, Paniello RC, Rich JT, Jackson R, Pipkorn P, Michel LS, Ley J, Oppelt P, Dunn GP, Barnell EK, Spies NC, Lin T, Li T, Mulder DT, Hanna Y, Cirlan I, Pugh TJ, Mudianto T, Riley R, Zhou L, Jo VY, Stachler MD, Hanna GJ, Kass J, Haddad R, Schoenfeld JD, Gjini E, Lako A, Thorstad W, Gay HA, Daly M, Rodig SJ, Hagemann IS, Kallogjeri D, Piccirillo JF, Chernock RD, Griffith M, Griffith OL, Adkins DR. Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus-Unrelated Head and Neck Cancer: A Multicenter, Phase II Trial. Clin Cancer Res. 2020 Oct 1;26(19):5140-5152. doi: 10.1158/1078-0432.CCR-20-1695. Epub 2020 Jul 14.

  PMID: 32665297 BACKGROUND

• Zandberg DP, Strome SE. The role of the PD-L1:PD-1 pathway in squamous cell carcinoma of the head and neck. Oral Oncol. 2014 Jul;50(7):627-32. doi: 10.1016/j.oraloncology.2014.04.003. Epub 2014 May 10.

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• 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.

  PMID: 34174189 BACKGROUND

• Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Nov 23;394(10212):1915-1928. doi: 10.1016/S0140-6736(19)32591-7. Epub 2019 Nov 1.

  PMID: 31679945 BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

camrelizumab; spartalizumab; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Ying Wang, Ph.D, M.D.

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Chongqing University Cancer Hospital

Study Record Dates

• First Submitted: January 16, 2022
• First Posted: January 28, 2022
• Study Start: January 1, 2022
• Primary Completion: February 8, 2026
• Study Completion: February 8, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)