GastrectomyPhase 2NCT07330063
Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Totally Laparoscopic Radical Distal Gastrectomy
A Phase 2 study testing Anruikefen (Intravenous Bolus) and Anruikefen (Intravenous Infusion) in people with Gastrectomy and Postoperative Analgesia, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Anruikefen is a peripherally highly selective kappa receptor agonist that does not easily cross the blood-brain barrier, resulting in a low incidence of central adverse reactions such as respiratory depression, sedation, and addiction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrectomy, Postoperative Analgesia
- What is being tested?
- Anruikefen (Intravenous Bolus) and Anruikefen (Intravenous Infusion)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2026to 30 Dec 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75 years old (inclusive).
- American Society of Anesthesiologists (ASA) physical status classification Class I-III.
- Body Mass Index (BMI) ranging from 18 kg/m² to 30 kg/m² (inclusive).
- Patients scheduled for elective total laparoscopic distal gastrectomy for gastric cancer under general anesthesia, with surgical duration < 5 hours.
- Surgical incision length < 8 cm.
- Voluntarily agree to participate in the trial and sign the informed consent form.
Who cannot join
- Patients undergoing emergency surgery or suffering from trauma.
- Patients who undergo conversion to open surgery or laparoscopically assisted distal gastrectomy for gastric cancer during the operation.
- Patients who refuse to receive Patient-Controlled Intravenous Analgesia (PCIA).
- Patients with a history of prior abdominal surgery.
- Patients expected to require prolonged endotracheal intubation after surgery.
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
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000
Bin Ke, binke@tmu.edu.cn
About this study
Anruikefen is a peripherally highly selective kappa receptor agonist that does not easily cross the blood-brain barrier, resulting in a low incidence of central adverse reactions such as respiratory depression, sedation, and addiction. As a Class 1 new drug, it was approved for marketing in China on May 13, 2025, and is indicated for the treatment of postoperative pain following abdominal surgery. Results from two Phase Ⅲ randomized controlled trials (RCTs) of Anruikefen have demonstrated its significant analgesic efficacy, with the incidence of postoperative nausea and vomiting (PONV) being 50% significantly lower than that in the placebo group, which confirms the favorable safety profile of Anruikefen Injection.
Therefore, this investigator-initiated trial (IIT) is designed to further verify the efficacy and safety of Anruikefen in patients undergoing total laparoscopic distal gastrectomy for gastric cancer.
- Conditions
- Gastrectomy, Postoperative Analgesia
- Being tested
- Anruikefen (Intravenous Bolus), Anruikefen (Intravenous Infusion), Placebo Group
- Keywords
- Anrikefon, kappa opioid receptor agonist, gastrectomy, Postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anruikefen (Intravenous Bolus)Drug
Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
Anruikefen (Intravenous Infusion)Drug
Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.
Placebo GroupDrug
Normal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Normal Saline via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses. Receives: Drug: Placebo Group |
| Anruikfen Intravenous Bolus Injection Group | Experimental | Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses. Receives: Drug: Anruikefen (Intravenous Bolus) |
| Anruikefen Intravenous Infusion Group | Experimental | Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses. Receives: Drug: Anruikefen (Intravenous Infusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Consumption of Sufentanil via PCIA
Measured: within 48 Hours after the First Administration Postoperatively
Secondary outcomes (18)
Cumulative consumption of sufentanil delivered via patient-controlled intravenous analgesia (PCIA)
Measured: From the end of surgery up to 24 hours after the first administration of study drug
Rest numerical rating scale (NRS) pain score assessed at baseline, 1 hour , 8 hours , 24 hours, and 48 hours after the first study drug administration;
Measured: Baseline (immediately before the first study drug administration), 1 hour ± 30 minutes, 8 hours ± 2 hours, 24 hours ± 2 hours, and 48 hours ± 2 hours after the first administration of study drug
Dynamic numerical rating scale (NRS) pain score assessed at baseline, 1 hour , 8 hours , 24 hours, and 48 hours after the first study drug administration;
Measured: Baseline (immediately before the first study drug administration), 1 hour ± 30 minutes, 8 hours ± 2 hours, 24 hours ± 2 hours, and 48 hours ± 2 hours after the first administration of study drug
Peak rest numerical rating scale (NRS) pain score
Measured: Within the period from 0 hours to 24 hours after the first administration of study drug
Peak dynamic numerical rating scale (NRS) pain score
Measured: Within the period from 0 hours to 24 hours after the first administration of study drug
Incidence of rescue antiemetic treatment administration
Measured: Within 48 hours after the first administration of study drug
I-FEED score
Measured: At 24 hours, 48 hours, 72 hours, and 96 hours after the first administration of study drug
Time in hours from the end of surgery to the first oral intake
Measured: Throughout the inpatient hospital stay after surgery
Time in hours from the end of surgery to the recovery of bowel function (defined as the first passage of flatus or first defecation)
Measured: Throughout the inpatient hospital stay after surgery
Levels of inflammatory factors (IL-6, IL-10, TNF-α, CRP, NLR)
Measured: Preoperative baseline (prior to surgery), before the first postoperative administration of study drug, and 48 hours after the first administration of study drug
Sleep quality （assessed via the Richards-Campbell Sleep Questionnaire） on the night of the first study drug administration
Measured: On the single night following the first administration of study drug
Time (hours) from the end of surgery to the first out-of-bed ambulation
Measured: Throughout the inpatient hospital stay following surgery
Total time (days) from surgery until patients meet discharge criteria
Measured: during hospitalization
Total hospital length of stay measured in calendar days at the time of participant discharge after surgery
Measured: At the moment of hospital discharge for each participant
Patient satisfaction score at 48 h after the first study drug administration
Measured: At 48 hours after the first administration of study drug
Overall patient recovery quality score evaluated via the QoR-15 questionnaire
Measured: At 24 hours, 48 hours, and 72 hours after the first administration of study drug
Incidence of Serious Adverse Events (SAEs)
Measured: Throughout the inpatient hospital stay following surgery
Incidence of Treatment-Emergent Adverse Events (TEAEs) related to the study drug
Measured: Throughout the inpatient hospital stay following surgery, during the period of study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start8 Apr 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrectomyStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Han Liang, MS, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330063
- Sponsor's protocol ID
- E20260874
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Totally Laparoscopic Radical Distal Gastrectomy
- ClinicalTrials.gov ID
- NCT07330063
- Acronym / sponsor ID
- E20260874
- Conditions
- Gastrectomy, Postoperative Analgesia
- Keywords
- Anrikefon, kappa opioid receptor agonist, gastrectomy, Postoperative analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Jan 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.
Anruikefen is a peripherally highly selective kappa receptor agonist that does not easily cross the blood-brain barrier, resulting in a low incidence of central adverse reactions such as respiratory depression, sedation, and addiction. As a Class 1 new drug, it was approved for marketing in China on May 13, 2025, and is indicated for the treatment of postoperative pain following abdominal surgery. Results from two Phase Ⅲ randomized controlled trials (RCTs) of Anruikefen have demonstrated its significant analgesic efficacy, with the incidence of postoperative nausea and vomiting (PONV) being 50% significantly lower than that in the placebo group, which confirms the favorable safety profile of Anruikefen Injection.
Therefore, this investigator-initiated trial (IIT) is designed to further verify the efficacy and safety of Anruikefen in patients undergoing total laparoscopic distal gastrectomy for gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: Placebo GroupNormal Saline via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses. |
| Anruikfen Intravenous Bolus Injection Group | Experimental | Drug: Anruikefen (Intravenous Bolus)Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses. |
| Anruikefen Intravenous Infusion Group | Experimental | Drug: Anruikefen (Intravenous Infusion)Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 75 years old (inclusive).
- American Society of Anesthesiologists (ASA) physical status classification Class I-III.
- Body Mass Index (BMI) ranging from 18 kg/m² to 30 kg/m² (inclusive).
- Patients scheduled for elective total laparoscopic distal gastrectomy for gastric cancer under general anesthesia, with surgical duration < 5 hours.
- Surgical incision length < 8 cm.
Key exclusion criteria (5 listed)
- Patients undergoing emergency surgery or suffering from trauma.
- Patients who undergo conversion to open surgery or laparoscopically assisted distal gastrectomy for gastric cancer during the operation.
- Patients who refuse to receive Patient-Controlled Intravenous Analgesia (PCIA).
- Patients with a history of prior abdominal surgery.
- Patients expected to require prolonged endotracheal intubation after surgery.
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 |
|---|---|---|
| Anruikefen (Intravenous Bolus)Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses. | Drug | Anruikfen Intravenous Bolus Injection Group |
| Anruikefen (Intravenous Infusion)Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses. | Drug | Anruikefen Intravenous Infusion Group |
| Placebo GroupNormal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses. | Drug | Placebo Group |
Primary outcome
Total Consumption of Sufentanil via PCIA
Time frame: within 48 Hours after the First Administration Postoperatively
18 secondary outcomes
Cumulative consumption of sufentanil delivered via patient-controlled intravenous analgesia (PCIA)
Time frame: From the end of surgery up to 24 hours after the first administration of study drug
Rest numerical rating scale (NRS) pain score assessed at baseline, 1 hour , 8 hours , 24 hours, and 48 hours after the first study drug administration;
Time frame: Baseline (immediately before the first study drug administration), 1 hour ± 30 minutes, 8 hours ± 2 hours, 24 hours ± 2 hours, and 48 hours ± 2 hours after the first administration of study drug
Dynamic numerical rating scale (NRS) pain score assessed at baseline, 1 hour , 8 hours , 24 hours, and 48 hours after the first study drug administration;
Time frame: Baseline (immediately before the first study drug administration), 1 hour ± 30 minutes, 8 hours ± 2 hours, 24 hours ± 2 hours, and 48 hours ± 2 hours after the first administration of study drug
Peak rest numerical rating scale (NRS) pain score
Time frame: Within the period from 0 hours to 24 hours after the first administration of study drug
Peak dynamic numerical rating scale (NRS) pain score
Time frame: Within the period from 0 hours to 24 hours after the first administration of study drug
Incidence of rescue antiemetic treatment administration
Time frame: Within 48 hours after the first administration of study drug
I-FEED score
Time frame: At 24 hours, 48 hours, 72 hours, and 96 hours after the first administration of study drug
Time in hours from the end of surgery to the first oral intake
Time frame: Throughout the inpatient hospital stay after surgery
Time in hours from the end of surgery to the recovery of bowel function (defined as the first passage of flatus or first defecation)
Time frame: Throughout the inpatient hospital stay after surgery
Levels of inflammatory factors (IL-6, IL-10, TNF-α, CRP, NLR)
Time frame: Preoperative baseline (prior to surgery), before the first postoperative administration of study drug, and 48 hours after the first administration of study drug
Sleep quality （assessed via the Richards-Campbell Sleep Questionnaire） on the night of the first study drug administration
Time frame: On the single night following the first administration of study drug
Time (hours) from the end of surgery to the first out-of-bed ambulation
Time frame: Throughout the inpatient hospital stay following surgery
Total time (days) from surgery until patients meet discharge criteria
Time frame: during hospitalization
Total hospital length of stay measured in calendar days at the time of participant discharge after surgery
Time frame: At the moment of hospital discharge for each participant
Patient satisfaction score at 48 h after the first study drug administration
Time frame: At 48 hours after the first administration of study drug
Overall patient recovery quality score evaluated via the QoR-15 questionnaire
Time frame: At 24 hours, 48 hours, and 72 hours after the first administration of study drug
Incidence of Serious Adverse Events (SAEs)
Time frame: Throughout the inpatient hospital stay following surgery
Incidence of Treatment-Emergent Adverse Events (TEAEs) related to the study drug
Time frame: Throughout the inpatient hospital stay following surgery, during the period of study drug administration
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 22 Sep 2026.
- 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.
Han Liang, MS principal investigator
Tianjin Medical University Cancer Institute and Hospital
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 Anruikefen (Intravenous Bolus) and Anruikefen (Intravenous Infusion) in people with Gastrectomy and Postoperative Analgesia, run by Tianjin Medical University Cancer Institute and 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 6 inclusion and 5 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 22 Sep 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. Some participants in this study may receive a placebo. 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?
Contact Bin Ke (022-23340123-1061, binke@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Consumption of Sufentanil via PCIA (time frame: within 48 Hours after the First Administration Postoperatively). 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 22 Sep 2026.