## Protocol Section
### Identification Module
**NCT ID:** NCT06435260

**Brief Title:** To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Locally Advanced Pancreatic Cancer

**Official Title:** To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Locally Advanced Pancreatic Cancer

#### Organization Study ID Info
**ID:** ARK-pancreatic-001
#### Organization
**Class:** OTHER
**Full Name:** Hebei Medical University Fourth Hospital
### Status Module
#### Completion Date
**Date:** 2027-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hebei Medical University Fourth Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**Brief Summary:** The purpose of this study is to assess surgical conversion rate and the immediate and long-term outcomes to patients who receive hypofractionated radiotherapy and AG combined with camrelizumab immunotherapy of locally advanced pancreatic cancer.

### Conditions Module

**Conditions:**

- Pancreatic Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Efficacy evaluation was performed within 2 weeks after the end of neoadjuvant therapy, surgical treatment was performed in patients assessed as operable and in those with a clear intention to undergo surgery, postoperative adjuvant chemotherapy and ICIs were determined according to the patient's tolerance and independent will, and enter the follow-up period.

**Intervention Names:**

- Drug: Camrelizumab+chemotherapy

- Radiation: hypofractionated radiotherapy

**Label:** Hypofractionated radiotherapy+Camrelizumab+chemotherapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Hypofractionated radiotherapy+Camrelizumab+chemotherapy

**Description:** Chemotherapy combined with ICIs was started 5-7 days after the completion of radiotherapy:

AG: intravenous nab-paclitaxel 125 mg/m2 and gemcitabine 1000mg/m2 d1,8, q3w, 4 cycles.

Camrelizumab: 200mg, iv, 30min, q3w, 4 cycles.

**Name:** Camrelizumab+chemotherapy

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Hypofractionated radiotherapy+Camrelizumab+chemotherapy

**Description:** Hypofractionated radiotherapy: pGTV:40Gy/5F, PTV≥25Gy/5F.

**Name:** hypofractionated radiotherapy

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Description:** There was no residual by the microscope

**Measure:** a.R0-resection rate

**Time Frame:** within 3 weeks after surgery

#### Secondary Outcomes

**Description:** The proportion of tumor markers in turned negative

**Measure:** Conversion to negative rate

**Time Frame:** up to 23 weeks

**Description:** Baseline to measured stable disease

**Measure:** Objective response rate (ORR)

**Time Frame:** tumor assessment every 6 weeks since the treatment began, up to 24 months

**Description:** Baseline to measured progressive disease

**Measure:** Disease control rate (DCR)

**Time Frame:** tumor assessment every 6 weeks since the treatment began, up to 24 months

**Description:** Baseline to measured date of death from any cause

**Measure:** 3-year Overall survival (OS)

**Time Frame:** 3 years

**Description:** DFS is defined as the time from registration to the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause. Patients without an event are censored at the date of last evaluation.

**Measure:** 3-year Disease Free Survival (DFS)

**Time Frame:** 3 years

**Description:** Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of participants with adverse events will be recorded at each treatment visit.

**Measure:** Adverse events

**Time Frame:** 3 years

**Description:** Evaluate the quality of life according to QOL-BREF. The number of participants with quality of life will be recorded at each treatment visit.

**Measure:** Quality of life

**Time Frame:** 1 years after therapy

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Age:18 to 75 years old, male or female;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
3. Tumor was located in the pancreas;
4. Pathological diagnosis was pancreatic ductal adenocarcinoma or acinar cell carcinoma;
5. No distant metastasis;
6. Clinical assessment was locally advanced (at least qualified one of the following criteria:①Lymph node metastasis outside the surgical area;②tumor surrounded more than half of the superior mesenteric vein;③tumor was adjacent to or wrapped more than half of the celiac artery;④Superior mesenteric vein or portal vein occlusion is not suitable for revascularization;⑤Invasion or wrapping of the aorta).
7. There was no history of immune system diseases, other malignant tumors, myocarditis, coronary heart disease, other cardiovascular and cerebrovascular diseases, thyroid dysfunction, liver and kidney diseases, psychiatric diseases, infectious diseases, or systemic diseases other than those mentioned above.

Participants were willing to join in this study, good adherence and written informed consent.

Exclusion Criteria:

1. Patients who did not meet these inclusion criteria;
2. Poor cognitive ability, inability to answer questions, inability to fill out questionnaires, or mental disorders;
3. The investigators think inappropriate.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** pengli72@sina.com

**Name:** Li Peng

**Phone:** 13933868818

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shijiazhuang

**Country:** China

**Facility:** Fourth Hospital of Hebei Medical University

**State:** Hebei

**Zip:** 050011

#### Overall Officials

**Official 1:**

**Affiliation:** Fourth Hospital of Hebei Medical

**Name:** Li Peng

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Fourth Hospital of Hebei Medical

**Name:** Fengpeng Wu

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: HIGH

- As Found: Pancreatic Cancer

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: HIGH

- As Found: Pancreatic Cancer

### Condition Browse Module - Meshes

- ID: D000010190

- Term: Pancreatic Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19537

- Name: Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M2985

- Name: Gemcitabine

- Relevance: LOW

- As Found: Unknown

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M2853

- Name: Immunomodulating Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
