Neoplasms

All Conditions

Carcinoma

Head and Neck Neoplasms

Patients receive Kate Farms pea protein oral nutrition supplement PO during their mealtimes as directed by their clinical dietitian during and up to 1 month following chemoradiation in the absence of unacceptable toxicity.

Given Kate Farms pea protein oral nutrition supplement PO

Dietary Supplement

Quality-of-Life Assessment

Questionnaire Administration

Vincent Basehart

Jackie Hernandez

Jie Deng

This phase II trial studies the effect of a plant-based oral nutrition supplement, Kate Farms Standard 1.4 and/or Standard 1.0. as a primary source of nutrition in reducing the gastrostomy tube placement rate in patients with head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced) and who are undergoing chemoradiation therapy. Gastrostomy tube (G-tube) placement can be used for enteral feedings and may lead to long term side effects such as swallowing dysfunction and lead to higher rates of permanent G-tube dependence. The Kate Farms pea protein oral nutrition supplement is formulated with organic, planted-based protein for easier digestibility without artificial sweeteners or additives and without common allergens such as dairy, soy, gluten or corn. It is nutritionally complete, calorie and protein dense and available in multiple flavors that can be consumed directly or as a base for other recipes. Giving pea protein oral nutrition supplement may provide nutritional support to decrease the need for therapeutic G-tube rate during chemoradiation compared to standard supportive care.

PRIMARY OBJECTIVE:

I. To determine the therapeutic G-tube placement rate during chemoradiation.

SECONDARY OBJECTIVES:

I. To determine percent weight change during and following treatment. II. To determine body mass index (BMI) changes during and following treatment. III. To determine changes in nutrition status based on Global Leadership Initiative on Malnutrition (GLIM) criteria IV. To determine lean body mass before and after treatment via psoas muscle surrogate measurement on routine staging scans.

V. To determine the adherence rate of Kate Farms oral nutritional replacement. VI. To determine changes in oral and gastrointestinal microbiota via 16s ribosomal ribonucleic acid (RNA) sequencing during and following treatment in an exploratory analysis.

VII. To determine changes in biomarkers during treatment. VIIa. Serum human papillomavirus (HPV) deoxyribonucleic (DNA). VIIb. 38-multiplex immune cytokine and chemokine panel in an exploratory analysis.

VIIc. Complete metabolic panel, complete blood count with differential, C-reactive protein (CRP).

VIId. Radiosensitivity germ-line biomarker panel. VIII. To determine physician-reported acute and late toxicities during and following treatment.

VIIIa. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. IX. To determine patient-reported quality of life during and following treatment.

IXa. University of Washington and Functional Assessment of Cancer Therapy questionnaires.

IXb. Functional Assessment of Cancer Therapy-Head \& Neck (FACT-H\&N). X. To determine clinical outcomes from treatment. Xa. Local/Locoregional control. Xb. Distant metastasis-free survival. Xc. Overall survival.

OUTLINE:

Patients receive Kate Farms pea protein oral nutrition supplement orally (PO) during their mealtimes as directed by their clinical dietitian during and up to 1 month following chemoradiation in the absence of unacceptable toxicity.

After completion of study intervention, patients are followed up for a minimum of 2 years.

Pea Protein Oral Nutrition Supplement for the Reduction of Gastrostomy Tube Placement Rate in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemoradiation Therapy

Intervention With Pea Protein Oral Nutrition Supplement Meal Replacement to Reduce Therapeutic Gastrostomy Tube Rates in Patients With Head and Neck Cancer Undergoing Chemoradiation Therapy

Will calculate the compliance rate and the corresponding 95% exact confidence interval.

Will calculate the compliance rate and the corresponding 95% exact confidence interval. The 95% exact confidence interval (CI) will be provided.

Weight data will be collected at each visit and summary descriptive statistics will be calculated at each time points. Repeated measure analysis of variance (ANOVA) will be used to explore if there are any change in these parameters over time. Treatment breaks will be recorded in days per study patient and summarized. G-tube placement timing will be recorded for patients receiving G-tubes, and the duration of G-tube dependence will be recorded in days per study patient and summarized.

BMI data will be collected at each visit and summary descriptive statistics will be calculated at each time points. Repeated measure ANOVA will be used to explore if there are any change in these parameters over time. Treatment breaks will be recorded in days per study patient and summarized. G-tube placement timing will be recorded for patients receiving G-tubes, and the duration of G-tube dependence will be recorded in days per study patient and summarized.

Will be collected at each visit and summary descriptive statistics will be calculated at each time points. Repeated measure ANOVA will be used to explore if there are any change in these parameters over time. Treatment breaks will be recorded in days per study patient and summarized. G-tube placement timing will be recorded for patients receiving G-tubes, and the duration of G-tube dependence will be recorded in days per study patient and summarized.

Patient-reported QOL according to the University of Washington (UW-QOL) questionnaires will be summarized by descriptive statistics by visit time points.

The University of Washington Quality of Life Questionnaire (UW-QOL) is a self-administered scale measuring health-related quality life specifically for head and neck cancer patients. It is scored from 0-100 with higher scores indicating a better quality of life.

Patient-reported QOL according to the Functional Assessment of Cancer Therapy-Head \& Neck (FACT-HN) questionnaires will be summarized by descriptive statistics by visit time points.

Functional Assessment of Cancer Therapy-Head \& Neck (FACT-HN) is a 12 item self-administered scale measuring health-related quality of life specifically for head and neck cancer patients. Response options form a Likert scale and a subscale score is computed by summing across all items, with higher scores reflecting better QOL.

Will be estimated using the Kaplan-Meier method.

Toxicity will be graded using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version (v) 4.0. AEs and serious (S)AEs will be reported using a CTCAE v 4.0 terminology and severity.

Kate Farms Inc

Jonsson Comprehensive Cancer Center

Rare Diseases

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Oral Squamous Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tislelizumab

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Neoadjuvant immunochemotherapy (albumin paclitaxel+cisplatin+tislelizumab) + radical surgery + adjuvant therapy (radiation/chemoradiation + tislelizumab maitainance)

Standard therapy of radical surgery +adjuvant therapy (radiation/chemoradiation)

Neoadjuvant immunochemotherapy (2 cycles, and 21 days each cycle, 260mg/m2 albumin paclitaxel intravenously on day 1 and day 22, with 75mg/m2 of cisplatin and 200mg of tislelizumab) + radical surgery + adjuvant therapy (radiation/chemoradiation followed by 200mg of tislelizumab, every 3 weeks for one year)

albumin paclitaxel, cispatin, tislelizumab

Lai-ping Zhong, MD, PhD

Ying-ying Huang, MD

Jing-song Li, MD, PhD

Xue-kui Liu, MD, PhD

Lei Tao, MD, PhD

Yu Wang, MD, PhD

Can-hua Jiang, MD, PhD

Li-song Lin, MD, PhD

Jian Meng, MD, PhD

Qi Zhu, MD, PhD

To evaluate the prognostic efficacy of neoadjuvant immunochemotherapy with tislelizumab, albumin paclitaxel and cisplatin followed by radical surgery and adjuvant therapy compared with standard therapy for patients with locally advanced and resectable oral squamous cell carcinoma.

Neoadjuvant therapy (NAT) is regarded as an effective way to reduce or downgrade the locally advanced or aggressive cancers, and to improve the chance of eradication of the locoregional lesions by radical surgery and/or radiotherapy. However, there are still debates on the clinical value of NAT for patients with locally advanced oral squamous cell carcinoma (LAOSCC). In a series of clinical trials on neoadjuvant therapy for LAOSCC have been carried out by our research group, the pathological efficacy of neoadjuvant immunochemotherapy is superior to neoadjuvant immunotarget therapy, neoadjuvant chemotarget therapy, or neoadjuvant chemotherapy. And in the neoadjuvant immunochemotherapy clinical trial (NCT04473716), the results of the safety and efficacy of neoadjuvant regimen showed that the neoadjuvant regimen of immunochemotherapy was well tolerated, with an MPR rate of 60% and 2-year OS of 90%, which were better than previously reported patients receiving standard treatment for LAOSCC. However, limited to single-arm clinical trial, the patients with LAOSCC benefit from neoadjuvant immunochemotherapy for survival, randomized controlled trials with larger sample size are needed. The aim of present trial is to evaluate the prognostic efficacy of 2-year survival rate in patients with LAOSCC receiving neoadjuvant immunochemotherapy with tiralizumab, albumin paclitaxel and cisplatin followed by radical surgery and adjuvant therapy compared with standard therapy.

The patients with LAOSCC would receive NAT with tiralizumab, albumin paclitaxel and cisplatin followed by radical surgery and adjuvant therapy (the experimental group) or radical surgery and adjuvant therapy (the control group). A total number of 134 patients will be recruited. Neoadjuvant immunochemotherapy: for the patients who are randomly assigned to the experimental group, the palpable edges of the primary lesion (both the longest and shortest axis) would be marked before NAT by at least four points, which is 0.5cm away; 260mg/m2 albuminpaclitaxel intravenously on day 1 and day 22, with 75mg/m2 of cisplatin at an hour interval and 200mg of tislelizumab at an hour interval will be performed. NAT will be given every 3 weeks for 2 cycles, unless there is disease progression, unacceptable toxic effects, or withdrawal of consent by the patients. Surgery will be performed within 2 weeks after completion of NAT. Surgery: Radical resection of the primary lesion and full neck dissection with proper reconstruction will be performed. The safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion; for patients who received NAT, the safety margins are 1.0cm away from the marks that were placed before NAT, to ensure the same extent surgery in both groups. Post-operative adjuvant therapy: radiotherapy will be arranged 4 to 6 weeks after surgery. Routine external beam radiotherapy, will be performed, and the dose is 1.8-2Gy/day, 5 days/week for 6 weeks, and totally 54-60Gy, in the patient with high risk features, concurrent chemotherapy with cisplatin of 80mg/m2 will be used; in the experimental group, adjuvant maintaining therapy of 200mg of tislelizumab, every 3 weeks, for one year will be used. A complete medical history will be obtained and tumor assessment will be performed at baseline. Clinical tumor response will be assessed by clinical evaluation, imaging evaluation will be characterized according to the criteria of response evaluation criteria in solid tumors (version 1.1) before surgery. Post-operative pathological response will be assessed by post-operative pathological examination. Patients will be followed-up by every three months in the first 2 years, every six months in the next 3-5 years, and once a year thereafter until death or data censoring. Overall survival will be calculated from the date of randomization to the date of death; event free survival will be calculated from the date of randomization to local recurrence, regional recurrence, distant metastasis, disease progress, or death; disease free survival will be calculated from the date of randomization to tumor recurrence or distant metastasis or death from any cause.

Randomized 1:1 to experimental or control arm. Experiment arm: neoadjuvant immunochemotherapy (2 cycles, and 21 days each cycle, 260mg/m2 albuminpaclitaxel intravenously on day 1 and day 22, with 75mg/m2 of cisplatin and 200mg of tislelizumab) + radical surgery + adjuvant therapy (radiation/chemoradiation followed by 200mg of tislelizumab, every 3 weeks for one year) Control arm: standard therapy of radical surgery +adjuvant therapy (radiation/chemoradiation)

Neoadjuvant Immunochemotherapy for LAOSCC

Neoadjuvant Immunochemotherapy With Tislelizumab, Albumin Paclitaxel and Cisplatin Followed by Standard Therapy Versus Standard Therapy for Locally Advanced Oral Squamous Cell Carcinoma, a Multicenter Randomized Phase 3 Trial

Event free survival is calculated from the date of randomization to local recurrence, regional recurrence, distant metastasis, disease progress, or death. The rate of 2-year event free survival is reported as the percentage of patients who are event free survival for 2 years from the date of randomization.

Overall survival is calculated from the date of randomization to death. The rate of 2-year overall survival is reported as the percentage of patients who are overall survival for 2 years from the date of randomization.

Disease free survival is calculated from the date of randomization to local recurrence, locoregional recurrence, distant metastasis, or death. The rate of 2-year disease free survival is reported as the percentage of patients who are disease free survival for 2 years from the date of randomization.

Major pathological response is based on the pathological examination on the post-operative specimens after neoadjuvant immunochemotherapy. The rate of major pathological response is reported as the percentage of patients who have major pathological response after NAT.

Sun Yat-sen University

Fudan University

Central South University

Fujian Medical University

Lai-ping Zhong

Professor

Symptoms and General Pathology

Recurrence

Disease Attributes

Dermatologic Agents

Central Nervous System Depressants

Nivolumab

Immunomodulating Agents

Dihematoporphyrin Ether

Trioxsalen

Hematoporphyrin Derivative

Ether

Hematoporphyrins

Immune Checkpoint Inhibitors

Photosensitizing Agents

Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.

Porfimer Sodium

Interstitial Illumination Photodynamic Therapy

Quality of Life Assessment

Kimberly Wooten, MD

ASK RPCI

This phase I trial studies the side effects of interstitial photodynamic therapy (I-PDT) in treating patients with head and neck cancer that has spread to other parts of the body or that has come back. Interstitial photodynamic therapy uses a light-sensitive drug called porfimer sodium. This drug is activated by laser light delivered through special fibers into the tumor.

In this study the doctors will evaluate the safety of I-PDT and determine the potentially effective light setting in this treatment.

PRIMARY OBJECTIVES:

I. To determine the safety of porfimer sodium (Photofrin) mediated interstitial photodynamic therapy (I-PDT) in patients with locally advanced or recurrent head and neck cancer (HNC) .

* To determine the recommended light irradiance dose for a future Phase 2 trial of Photofrin® mediated I-PDT in patients with locally advanced or recurrent HNC

EXPLORATORY OBJECTIVES:

I . To access the objective tumor response rate

OUTLINE: This is a phase I study .

Patients receive porfimer sodium intravenously (IV) over 3-5 minutes and undergo I-PDT approximately 48 hours later.

After completion of study treatment, patients are followed up every 1-3 months for the first year, 2-6 months for 2nd year, and annually up to 5 years.

Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer

A Phase 1 Trial: Porfimer Sodium Mediated Interstitial Photodynamic for the Treatment of Patients With Locally Advanced or Recurrent Head and Neck Cancer

The frequency of toxicities will be tabulated by grade across all dose levels and cycles. All subjects who receive any study treatment will be considered evaluable for toxicity. Sequential boundaries will be used to monitor the serious adverse event (SAE) rate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pea Protein Oral Nutrition Supplement for the Reduction of Gastrostomy Tube Placement Rate in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemoradiation Therapy	NCT05115760	Locally Advance...	Dietary Supplem... Quality-of-Life... Questionnaire A...	18 Years -	Jonsson Comprehensive Cancer Center
Neoadjuvant Immunochemotherapy for LAOSCC	NCT06258811	Oral Squamous C... Locally Advance...	albumin paclita...	18 Years - 75 Years	Huashan Hospital
Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer	NCT03727061	Recurrent Head ... Locally Advance...	Nivolumab Porfimer Sodium Interstitial Il... Quality of Life...	18 Years -	Roswell Park Cancer Institute
Neoadjuvant Immunochemotherapy for LAOSCC	NCT06258811	Oral Squamous C... Locally Advance...	albumin paclita...	18 Years - 75 Years	Huashan Hospital
Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer	NCT03727061	Recurrent Head ... Locally Advance...	Nivolumab Porfimer Sodium Interstitial Il... Quality of Life...	18 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for locally advanced head and neck carcinoma