Study to compare the longevity of life between using low-dose immunotherapy before surgery and only surgery alone for advanced stage oral cancer

Phase 3

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2024/04/065574
• Lead Sponsor: Tata Memorial Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Subjects must have T3 N1/N2/N3 or T4 HNSCC of the oral cavity

2. Age: Male or female or transgender subjects aged more than 18 years.

3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.

4. Subjects must have normal organ and marrow function as per institute protocols

5. Patients with HIV are potentially eligible, as long as they have a CD4 count 200, are on concurrent HAART (highly active antiretroviral therapy), and have absence of active AIDS defining conditions.

6. Both men and women of all races and ethnic groups are eligible for this study.

7. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals and or nature of required assessments.

8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

1. Subjects who are receiving any other investigational agents.

2. Within 2 weeks of administration of a chemotherapeutic agent.

3. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses less than 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) d. Steroids for raised intracranial pressure due to the disease itself e,Steroid use for avoidance or treatment of emesis.

4. Uncontrolled comorbidities including active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent. Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke (less 6 months prior to enrollment), myocardial infarction (less 6 months prior to enrollment), unstable angina, congestive heart failure ( New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. Patients with severe renal and liver dysfunction Child Pugh B or C

5. Prior organ transplantation including allogeneic stem-cell transplantation.

6. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE v5.0 Grade 3).

7. Pregnant and lactating women are excluded from this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified