Pancreatic Cancer Non-resectablePhase 2NCT07386704
Nimotuzumab Combined With Chemoradiotherapy in the Treatment of Unresectable Locally Advanced or Oligometastatic Pancreatic Cancer
A Phase 2 study testing Nimotuzumab combined with chemoradiotherapy in people with Pancreatic Cancer Non-resectable, run by Peking University First Hospital at 1 site in China.
Trial summary
This study is a prospective, single-arm trial, aiming to enroll 30 patients with unresectable locally advanced or oligometastatic pancreatic cancer. The study will evaluate the efficacy and safety of nintedanib combined with radiotherapy and chemotherapy (gemcitabine or capecitabine monotherapy). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer Non-resectable
- What is being tested?
- Nimotuzumab combined with chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2025to 9 Dec 2027
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed by histological or cytological examination as pancreatic adenocarcinoma;
- Confirmed by imaging as locally advanced or oligometastatic (number of metastatic lesions ≤ 3);
- Evaluated by the clinical doctor as inoperable or the patient refuses surgery;
- ECOG PS score 0-1;
- No radiotherapy has been performed on the upper abdomen before, and no any palliative chemotherapy or other systemic anti-tumor treatment has been received;
- According to the RECIST 1.1 evaluation criteria, there are measurable lesions;
- Sufficient organ and bone marrow functions
Who cannot join
- Previous history of abdominal radiotherapy.
- Those with a history of other malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ).
- Those allergic to the drugs or their components used in this protocol.
- Those with known HIV or syphilis infection, or currently in the active stage of hepatitis (hepatitis B or hepatitis C).
- Those who have undergone major surgery within 30 days before screening.
- Those who have used EGFR monoclonal antibody or EGFR-TKI within 30 days before screening.
- Pregnant or lactating women.
- Those judged by the investigator to have other reasons unsuitable for participating in this study.
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
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: A Prospective, Single-arm Study of Nimotuzumab Combined With Radiotherapy and Chemotherapy in the Treatment of Unresectable Locally Advanced or Oligometastatic Pancreatic Cancer
This study is a prospective, single-arm trial, aiming to enroll 30 patients with unresectable locally advanced or oligometastatic pancreatic cancer. The study will evaluate the efficacy and safety of nintedanib combined with radiotherapy and chemotherapy (gemcitabine or capecitabine monotherapy). The primary endpoint of this study is the 1-year local control rate (LCR).
Read the detailed description
- Radiotherapy: Conventional fractionated radiotherapy or SBRT can be selected.
- Conventional Fractionated Radiotherapy: Pancreatic tumor + 5mm PTV 50-60Gy/25 fractions/5W; Pancreatic tumor GTV 60-70Gy/25 fractions/5W; If there are suspected metastatic lymph node regions, prophylactic irradiation of lymph node drainage areas should be performed.
- Stereotactic Body Radiotherapy (SBRT): Pancreatic tumor + 5mm PTV 30Gy/5 fractions/5 days; Pancreatic tumor GTV 40Gy/5 fractions/5 days.
- Nintuzumab: Nintuzumab 400mg, intravenous infusion, on day 1, administered once a week (QW). Mix400 mg of nintuzumab injection with 250ml of sodium chloride solution, and the infusion time should be more than 60 minutes. Administer concurrently during radiotherapy and discontinue use after radiotherapy.
- Chemotherapy (either tegafur or capecitabine, choose one):
- Tegafur-gimeracil-oteracil (S-1): 80-120mg per day, taken twice a day, from day 1 to day 14, and from day 21 onwards. One treatment cycle consists of 21 days.
- Capecitabine: 2000mg per square meter per day, taken twice a day, from day 1 to day 14, and from day 21 onwards. One treatment cycle consists of 21 days.
Continue the treatment until the disease progresses or an intolerable toxic reaction occurs.
- Conditions
- Pancreatic Cancer Non-resectable
- Being tested
- Nimotuzumab combined with chemoradiotherapy
- Keywords
- locally advanced, oligometastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimotuzumab combined with chemoradiotherapyDrug
The patient received treatment with nimotuzumab combined with radiotherapy and chemotherapy. The radiotherapy could be conducted using conventional fractionated radiotherapy or SBRT, and the chemotherapy could be carried out using tegafur or capecitabine.
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab + chemoradiotherapy group | Experimental | Not described Receives: Drug: Nimotuzumab combined with chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
LCR
Local Control Rate
Measured: The 1-year local control rate (LCR) of patients receiving nivolumab combined with radiotherapy and chemotherapy
Secondary outcomes (2)
OS
overall survival
Measured: The survival rates for 1 year, 2 years, and 5 years
PFS
Progression-free survival
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start9 Dec 2025
- Primary completion9 Dec 2026 (estimated)
- Study completion9 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Non-resectableStudies of the same condition, open and under way.
- More trials run by Peking University First 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386704
- Sponsor's protocol ID
- PRO-A
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Study of Nimotuzumab Combined With Radiotherapy and Chemotherapy in the Treatment of Unresectable Locally Advanced or Oligometastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07386704
- Acronym / sponsor ID
- PRO-A
- Conditions
- Pancreatic Cancer Non-resectable
- Keywords
- locally advanced, oligometastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 9 Dec 2026 (estimated)
- Study completion
- 9 Dec 2027 (estimated)
- First posted
- 4 Feb 2026 (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.
This study is a prospective, single-arm trial, aiming to enroll 30 patients with unresectable locally advanced or oligometastatic pancreatic cancer. The study will evaluate the efficacy and safety of nintedanib combined with radiotherapy and chemotherapy (gemcitabine or capecitabine monotherapy). The primary endpoint of this study is the 1-year local control rate (LCR).
Detailed description
- Radiotherapy: Conventional fractionated radiotherapy or SBRT can be selected.
- Conventional Fractionated Radiotherapy: Pancreatic tumor + 5mm PTV 50-60Gy/25 fractions/5W; Pancreatic tumor GTV 60-70Gy/25 fractions/5W; If there are suspected metastatic lymph node regions, prophylactic irradiation of lymph node drainage areas should be performed.
- Stereotactic Body Radiotherapy (SBRT): Pancreatic tumor + 5mm PTV 30Gy/5 fractions/5 days; Pancreatic tumor GTV 40Gy/5 fractions/5 days.
- Nintuzumab: Nintuzumab 400mg, intravenous infusion, on day 1, administered once a week (QW). Mix400 mg of nintuzumab injection with 250ml of sodium chloride solution, and the infusion time should be more than 60 minutes. Administer concurrently during radiotherapy and discontinue use after radiotherapy.
- Chemotherapy (either tegafur or capecitabine, choose one):
- Tegafur-gimeracil-oteracil (S-1): 80-120mg per day, taken twice a day, from day 1 to day 14, and from day 21 onwards. One treatment cycle consists of 21 days.
- Capecitabine: 2000mg per square meter per day, taken twice a day, from day 1 to day 14, and from day 21 onwards. One treatment cycle consists of 21 days.
Continue the treatment until the disease progresses or an intolerable toxic reaction occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab + chemoradiotherapy group | Experimental | Drug: Nimotuzumab combined with chemoradiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed by histological or cytological examination as pancreatic adenocarcinoma;
- Confirmed by imaging as locally advanced or oligometastatic (number of metastatic lesions ≤ 3);
- Evaluated by the clinical doctor as inoperable or the patient refuses surgery;
- ECOG PS score 0-1;
- No radiotherapy has been performed on the upper abdomen before, and no any palliative chemotherapy or other systemic anti-tumor treatment has been received;
Key exclusion criteria (8 listed)
- Previous history of abdominal radiotherapy.
- Those with a history of other malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ).
- Those allergic to the drugs or their components used in this protocol.
- Those with known HIV or syphilis infection, or currently in the active stage of hepatitis (hepatitis B or hepatitis C).
- Those who have undergone major surgery within 30 days before screening.
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 |
|---|---|---|
| Nimotuzumab combined with chemoradiotherapyThe patient received treatment with nimotuzumab combined with radiotherapy and chemotherapy. The radiotherapy could be conducted using conventional fractionated radiotherapy or SBRT, and the chemotherapy could be carried out using tegafur or capecitabine. | Drug | Nimotuzumab + chemoradiotherapy group |
Primary outcome
LCR
Time frame: The 1-year local control rate (LCR) of patients receiving nivolumab combined with radiotherapy and chemotherapy
Local Control Rate
2 secondary outcomes
OS
Time frame: The survival rates for 1 year, 2 years, and 5 years
PFS
Time frame: Every 3 months
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 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimotuzumab combined with chemoradiotherapy in people with Pancreatic Cancer Non-resectable, run by Peking University First 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 8 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: enrolling by invitation, as of the sponsor's last update on 4 Feb 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LCR (time frame: The 1-year local control rate (LCR) of patients receiving nivolumab combined with radiotherapy and chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2026.