Pancreatic CancerPhase 3ADJUPANCNCT06427447
Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC)
A Phase 3 study testing Adjuvant chemoradiotherapy and Adjuvant chemotherapy in people with Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
Trial summary
In this trial, we aim to compare the outcomes of adjuvant chemoradiotherapy with chemotherapy for patients with resected pancreatic cancer who are at high risk of disease progressions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Adjuvant chemoradiotherapy and Adjuvant chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 770 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2024to 30 Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years
- Pathologically confirmed pancreatic ductal adenocarcinoma
- Pathologically confirmed lymph node metastasis, R1 or R2 resection or lymphovascular invasion (one of the risk factors)
- No history of cancer treatment after surgical resection
- No disease progression confirmed by imaging examinations
- ECOG 0 to1 point
- No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10^9/L, neutrophil count ≥2.0×10^9, hemoglobin level ≥100g/L, platelet count ≥100×10^9/L, ALT and AST level < 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio <2)
Who cannot join
- History of cancer treatment after surgical resection
- History of other cancers within 5 years
- Disease progression, including local pprogression or metastasis, confirmed by imaging examinations
- ECOG ≥2 points
- Significant abnormality in blood routine test, liver and kidney function test and coagulation test
- Active inflammatory bowel disease
Show all 10Show fewer
- Gastrointestinal bleeding or perforation within 6 months
- Infections requiring antibiotics
- Heart or respirotory insufficiency
- Pregnant women or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huojun Zhang
Shanghai, Shanghai Municipality, 200433
Xiaofei Zhu, M.D., 86-021-31162222, zhuxiaofei_zxf@163.com
Huojun Zhang, M.D.
About this study
Official title: Adjuvant Chemoradiotherapy Versus Chemotherapy for Post-operative Pancreatic Cancer
In this trial, we aim to compare the outcomes of adjuvant chemoradiotherapy with chemotherapy for patients with resected pancreatic cancer who are at high risk of disease progressions.
Read the detailed description
Pancreatic cancer is a lethal malignancy with the lowest 5-year overall survival rate of 9% and an increasing incidence. In China, the mortality of pancreatic cancer ranked the sixth among all cancers. Although surgical resection is the only radical treatment, only less than 20% patients could receive upfront surgery at the initial diagnosis. Even though patients have surgery, the incidence of disease progressions, including local progression and metastasis, is about 80-90%. In NCCN guidelines and Chinese guidelines, adjuvant chemotherapy is recommended for post-operative pancreatic cancer, while adjuvant chemoradiotherapy could also be used. However, it has not been clarified that which patients may benefit from adjuvant chemoradiotherapy, and no high-level evidence has shown the advantages of adjuvant chemoradiotherapy over chemotherapy. In meta-analyses, it was demonstrated that patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion could achieve longer survival after adjuvant chemoradiotherapy compared with chemotherapy. Therefore, we aim to compare the outcomes of adjuvant chemoradiotherapy with those of chemotherapy in patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion after surgical resection of pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- Adjuvant chemoradiotherapy, Adjuvant chemotherapy
- Keywords
- pancreatic cancer, adjuvant chemoradiotherapy, adjuvant chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant chemoradiotherapyCombination product
Upfront chemotherapy (gemcitabine plus capecitabine) followed chemoradiotherapy (radiotherapy with concurrent capecitabine)
Adjuvant chemotherapyDrug
Chemotherapy (gemcitabine plus capecitabine)
| Study group | Role | What they receive |
|---|---|---|
| adjuvant chemoradiotherapy | Experimental | Chemotherapy: Gemcitabine plus capecitabine Gemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 1650-2000mg/m2，bid, d1-14, every 3 weeks as acycle. A total of 6 cycle should be delivered.
Chemoradiotherapy: 2-3 weeks after chemotherapy, adjuvant chemoradiotherapy is given. Radiation dose: 50-54Gy (1.8-2.0Gy per fraction). Concurrent capecitabine, 1650mg/m2，bid. Receives: Combination Product: Adjuvant chemoradiotherapy |
| adjuvant chemotherapy | Active comparator | Gemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 1650-2000mg/m2，bid, d1-14, every 3 weeks as acycle. A total of 6 cycle should be delivered. Receives: Drug: Adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression free survival will be determined.
The time from the start of treatment until documentation of any clinical or radiological disease progression or death, whichever occurred first. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 3 years
Secondary outcomes (3)
Overall survival will be determined.
The time from the randomization to death.
Measured: 3 years
Treatment-related adverse events will be determined.
Treatment-related adverse effects are determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 3 years
Quality of life will be determined.
The analysis of quality of life is based on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30). All scales and subscales range from 0 to 100. Regarding physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning and global health, higher scores may indicate better outcomes. In the case of fatigue, nausea and vomitting, pain, dyspnea, insomina, appetite loss, constipation, diarrhea and financial difficulties, lower scores may indicate better outcomes. Scales of all items are independent and not combined to compute a total score.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start6 Aug 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Huo Jun, Changhai Hospital
- Investigators
- Huojun Zhang, M.D., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427447
- Sponsor's protocol ID
- CH hospital
- Acronym
- ADJUPANC
- Status last verified
- May 2024
- First submitted
- 19 May 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu X, Liu W, Jiang L, Cao Y, Ye Y, Yu C, Yin X, Zhang H. ADJUPANC protocol: a phase III study of adjuvant chemotherapy versus chemoradiotherapy for pancreatic cancer. Future Oncol. 2025 Aug;21(18):2269-2273. doi: 10.1080/14796694.2025.2522061. Epub 2025 Jun 29.
PubMed 40583350
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chemoradiotherapy Versus Chemotherapy for Post-operative Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06427447
- Acronym / sponsor ID
- ADJUPANC / CH hospital
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, adjuvant chemoradiotherapy, adjuvant chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this trial, we aim to compare the outcomes of adjuvant chemoradiotherapy with chemotherapy for patients with resected pancreatic cancer who are at high risk of disease progressions.
Detailed description
Pancreatic cancer is a lethal malignancy with the lowest 5-year overall survival rate of 9% and an increasing incidence. In China, the mortality of pancreatic cancer ranked the sixth among all cancers. Although surgical resection is the only radical treatment, only less than 20% patients could receive upfront surgery at the initial diagnosis. Even though patients have surgery, the incidence of disease progressions, including local progression and metastasis, is about 80-90%. In NCCN guidelines and Chinese guidelines, adjuvant chemotherapy is recommended for post-operative pancreatic cancer, while adjuvant chemoradiotherapy could also be used. However, it has not been clarified that which patients may benefit from adjuvant chemoradiotherapy, and no high-level evidence has shown the advantages of adjuvant chemoradiotherapy over chemotherapy. In meta-analyses, it was demonstrated that patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion could achieve longer survival after adjuvant chemoradiotherapy compared with chemotherapy. Therefore, we aim to compare the outcomes of adjuvant chemoradiotherapy with those of chemotherapy in patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion after surgical resection of pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adjuvant chemoradiotherapy | Experimental | Combination Product: Adjuvant chemoradiotherapyChemotherapy: Gemcitabine plus capecitabine Gemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 1650-2000mg/m2，bid, d1-14, every 3 weeks as acycle. A total of 6 cycle should be delivered. Chemoradiotherapy: 2-3 weeks after chemotherapy, adjuvant chemoradiotherapy is given. Radiation dose: 50-54Gy (1.8-2.0Gy per fraction). Concurrent capecitabine, 1650mg/m2，bid. |
| adjuvant chemotherapy | Active comparator | Drug: Adjuvant chemotherapyGemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 1650-2000mg/m2，bid, d1-14, every 3 weeks as acycle. A total of 6 cycle should be delivered. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-75 years
- Pathologically confirmed pancreatic ductal adenocarcinoma
- Pathologically confirmed lymph node metastasis, R1 or R2 resection or lymphovascular invasion (one of the risk factors)
- No history of cancer treatment after surgical resection
- No disease progression confirmed by imaging examinations
Key exclusion criteria (10 listed)
- History of cancer treatment after surgical resection
- History of other cancers within 5 years
- Disease progression, including local pprogression or metastasis, confirmed by imaging examinations
- ECOG ≥2 points
- Significant abnormality in blood routine test, liver and kidney function test and coagulation test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant chemoradiotherapyUpfront chemotherapy (gemcitabine plus capecitabine) followed chemoradiotherapy (radiotherapy with concurrent capecitabine) | Combination product | adjuvant chemoradiotherapy |
| Adjuvant chemotherapyChemotherapy (gemcitabine plus capecitabine) | Drug | adjuvant chemotherapy |
Primary outcome
Disease progression free survival will be determined.
Time frame: 3 years
The time from the start of treatment until documentation of any clinical or radiological disease progression or death, whichever occurred first. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
3 secondary outcomes
Overall survival will be determined.
Time frame: 3 years
Treatment-related adverse events will be determined.
Time frame: 3 years
Quality of life will be determined.
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Derived from this study: PubMed 40583350Zhu X, Liu W, Jiang L, Cao Y, Ye Y, Yu C, Yin X, Zhang H. ADJUPANC protocol: a phase III study of adjuvant chemotherapy versus chemoradiotherapy for pancreatic cancer. Future Oncol. 2025 Aug;21(18):2269-2273. doi: 10.1080/14796694.2025.2522061. Epub 2025 Jun 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huojun Zhang, M.D. principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adjuvant chemoradiotherapy and Adjuvant chemotherapy in people with Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaofei Zhu (86-021-31162222, zhuxiaofei_zxf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease progression free survival will be determined. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06427447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.