## Protocol Section
### Identification Module
**NCT ID:** NCT04591379

**Brief Title:** Intratumoral Influenza Vaccine for Early Colorectal Cancer

**Official Title:** Intratumoral Influenza Vaccine for Early Colorectal Cancer

#### Organization Study ID Info
**ID:** REG-083-2020
#### Organization
**Class:** OTHER
**Full Name:** Zealand University Hospital
### Status Module
#### Completion Date
**Date:** 2021-11-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-12-13

**Type:** ACTUAL

**Last Update Submit Date:** 2022-12-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-09-22

**Type:** ACTUAL

#### Start Date
**Date:** 2021-02-26

**Type:** ACTUAL

**Status Verified Date:** 2022-12

#### Study First Post Date
**Date:** 2020-10-19
**Type:** ACTUAL
**Study First Submit Date:** 2020-09-07
**Study First Submit QC Date:** 2020-10-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Copenhagen

#### Lead Sponsor

**Class:** OTHER

**Name:** Zealand University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The aim of this explorative phase II clinical trial is to establish the safety and efficacy of intratumoral influenza vaccine in patients with colorectal cancer, as an additive treatment prior to intended curative surgery.

**Detailed Description:** This is an explorative phase 2 clinical trial which will be conducted in two phases. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with intratumoral influenza vaccine as a down staging and immune response enhancing treatment prior to intended curative surgery.

The first part of the study will be conducted as a pilot study. Six patients with histologically verified or clinically suspicious sigmoid colon cancer who are planned to undergo curative surgery will be included. Patients will be recruited from the Department of Surgery, Zealand University Hospital after their case has been reviewed by the multidisciplinary team (MDT). Standard treatment involves intended curative surgery within two weeks after the diagnosis. The treatment will be performed within a few days and it will be ensured that the experimental treatment will not lead to a significant delay of intended curative surgery.

If the pilot study finishes without violating any stop rules and without any serious adverse events the second part of the study will be initiated. This will be conducted as a phase 2 study where 24 patients with histologically verified or clinically suspicious sigmoid colon cancer and rectal cancer will be included. Patients will be recruited from the Department of Surgery, Zealand University Hospital after their case has been reviewed by the multidisciplinary team (MDT). Standard treatment involves intended curative surgery within two weeks after the diagnosis. The treatment will be performed within a few days and it will be ensured that the experimental treatment will not lead to a significant delay of intended curative surgery.

### Conditions Module

**Conditions:**

- Colorectal Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Influenza Vaccines

**Label:** Intervention arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention arm

**Description:** Intratumoral application of an unattenuated influenza vaccine

**Name:** Influenza Vaccines

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** To investigate if the treatment will induce a systemic immunologic response.

**Measure:** Efficacy - systemic immunological changes

**Time Frame:** Blood samples from the day of treatment (day 0), before surgery (day 7-14 after treatment), after surgery (postOP day 1-2) and postoperative follow-up (postOP day 12-16)

**Description:** To assess quality of recovery for patients recruited into this trial. A quality of recovery questionnaire (QoR-15) will be given to patients pre- and post-treatment.

**Measure:** Quality of recovery

**Time Frame:** Assessed before treatment (day 0), before surgery (day 7-14 after treatment), after surgery (postOP day 1) and postoperative follow-up (postOP day 12-16)

#### Primary Outcomes

**Description:** To investigate if intratumoral influenza vaccine is a safe treatment modality for tumor down staging prior to intended curative surgery in patients undergoing treatment for colorectal cancer.

Adverse events / reactions are recorded from day of treatment (Day 0) until the surgery, as it will be difficult to differ between adverse events/reactions to the experimental treatment or surgery. All adverse events / reactions should be described in medical terminology in the patient's file and recorded in case report forms (CRF). The following information must be recorded: start date/date when observed, severity, any initiated treatment, assessment of the AE if it meets the criteria for SAE, end date, and relationship to study drug. For AEs that meet the criteria for SAE, the outcome must be recorded.

**Measure:** Safety - Adverse reactions are classified according to CTCAE version 4.0

**Time Frame:** Day of surgery (day 7-14 after treatment)

#### Secondary Outcomes

**Description:** To investigate if intratumoral influenza vaccine will induce immunologic invasion of the primary tumor This will be analyzed by immunhistochemistry and NanoString

**Measure:** Efficacy - local immunological changes

**Time Frame:** Pathological specimens from day of treatment (day 0) and surgery (day 7-14 after treatment)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients must be mentally capable of understanding the information given.
* Patients must give written informed consent.
* Clinically suspected or histologically verified malignant tumor of the rectum or sigmoid colon.
* Tumor described as passable at index endoscopy.
* Men or women aged at least 18 years.
* Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection.

Exclusion Criteria:

* Highly inflamed gastrointestinal tissue which is ulcerated and bleeding
* Ongoing immunosuppressive treatment.
* Concurrent treatment with an investigational medicinal product.
* Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments.
* Advanced tumor stages, clinical UICC stage IV.
* Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery
* Acute surgical resection.
* Pregnancy
* Any previous allergic reaction to influenza vaccine or constituents, egg and chicken proteins, neomycin, formaldehyde or octoxinol-9
* Acute febrile illness
* Acute infectious disease
* Influenza vaccine administered within 30 days before study inclusion

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Køge

**Country:** Denmark

**Facility:** Zealand University Hospital

**State:** Zealand

**Zip:** 4600

#### Overall Officials

**Official 1:**

**Affiliation:** Zealand University Hospital

**Name:** Ismail Gögenur, Professor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Info Types:**

- STUDY_PROTOCOL

- ICF

**IPD Sharing:** YES

**Time Frame:** Study protocol and informed consent form will be available upon start of recruitment of patients

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10295

- Name: Influenza, Human

- Relevance: LOW

- As Found: Unknown

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Cancer

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015179

- Term: Colorectal Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
