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NCT Number: NCT06435260

Hypofractionated Radiotherapy +Chemotherapy+ Camrelizumab as Neoadjuvant Therapy for Pancreatic Cancer

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 Borderline Resectable/locally advanced pancreatic cancer.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location status: Recruiting

Location contact

Fengpeng Wu

PRINCIPAL_INVESTIGATOR

Li Peng

CONTACT

[email protected]

13933868818

Li Peng

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age:18 to 75 years old, male or female;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  • Tumor was located in the pancreas;
  • Pathological diagnosis was pancreatic ductal adenocarcinoma or acinar cell carcinoma;
  • No distant metastasis;
  • The pancreatic tumor is located more than 1cm away from the duodenum;
  • Clinical assessment was locally advanced or critical for resectable.

Locally advanced pancreatic cancer diagnostic criteria: (1) due to tumor invasion, venous occlusion or involving a wide range of superior mesenteric vein branch of jejunum, cannot safely - superior mesenteric vein reconstruction. ② (pancreatic head/uncinate process tumors) tumor contact with superior mesenteric artery or celiac artery > 180°. Tumor contact with superior mesenteric artery or coeliac trunk artery > 180°, tumor contact with coeliac trunk artery and invasion of abdominal aorta.

Critical for resectable pancreatic cancer diagnostic criteria: (1) contact with portal vein tumor - superior mesenteric vein > 180 °, 180 ° or less or contact combined intravenous contour irregular or venous thrombosis, but safety is complete resection and reconstruction; The tumor contacted the inferior vena cava. ② (pancreatic head/uncinate process tumors) the tumors contacting the common hepatic artery, but not involving the celiac artery or the origin of the left and right hepatic arteries, can be completely resected and safely reconstructed; Superior mesenteric artery tumor contact 180 ° or less; The tumor contacts the aberrant arteries (such as accessory right hepatic artery, alternative right hepatic artery, alternative common hepatic artery, etc.). (pancreatic body and tail tumors) tumor contact with superior mesenteric artery ≤180°; Tumor contact with celiac artery ≤180°; 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

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

Treatment and study plan

Camrelizumab+chemotherapy

Drug

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.

Hypofractionated radiotherapy

Radiation

Hypofractionated radiotherapy:PGTV=30Gy/5F(PTV≥25Gy/5F),

Primary outcomes

  1. a.R0-resection rate

    Time frame: One week after surgery

    The tumor was completely removed during surgery, and the cutting margins were also negative when viewed microscopically

Secondary outcomes

  1. Surgical conversion rate

    Time frame: 2 to 4 weeks after neoadjuvant therapy

    Tumors that were otherwise unresectable were transformed into surgically resectable tumors.

  2. Tumor regression rate

    Time frame: One week after surgery

    Degree of tumor response to neoadjuvant therapy

  3. Objective response rate (ORR)

    Time frame: through study completion,an average of 3 year

    It refers to the proportion of patients who achieve a prespecified reduction in tumor volume (CR/PR) and maintain the minimum time requirements according to accepted response evaluation criteria (e.g., RECIST in solid tumors, version 1.1).

  4. Disease control rate (DCR)

    Time frame: through study completion,an average of 3 year

    It refers to the proportion of patients who achieve a prespecified reduction in tumor volume (CR/PR/SD) and maintain the minimum time requirements according to accepted response evaluation criteria (e.g., RECIST in solid tumors, version 1.1).

  5. 3-year Overall survival (OS)

    Time frame: Three years from enrollment

    The time between the start of randomization and death from any cause

  6. 3-year Event Free Survival (EFS)

    Time frame: Three years from enrollment

    The time from randomization until disease progression, treatment discontinuation for any cause, or death.

  7. Adverse events

    Time frame: From enrollment to the end of treatment at 8 weeks

    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.

  8. Quality of life scores

    Time frame: 1 years after therapy

    Evaluate the quality of life according to The World Health Organization quality of life (WHOQOL) -BREF. The minimum value is 1, the maximum value is 5. And higher scores mean a better outcome. The number of participants with quality of life will be recorded at each treatment visit.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Hebei Medical University Fourth Hospital

Other

Registry information

Official study title

To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Borderline Resectable/Locally Advanced Pancreatic Cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
May 30, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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