NCT07026149

Brief Summary

The study is being conducted to evaluate the efficacy, safety and tolerability of radiotherapy and chemotherapy, apatinib with camrelizumab in the neoadjuvant (prior to surgery) and adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
50mo left

Started Jun 2025

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Jun 2025May 2030

Study Start

First participant enrolled

June 8, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2030

Expected
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 10, 2025

Last Update Submit

June 10, 2025

Conditions

Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Pathological Complete Response

    Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment

Secondary Outcomes (8)

  • Total Pathological Complete Response (tpCR)

    Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment

  • Major pathological response(MPR)

    Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment

  • Margin-free (R0) resection rate

    Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment

  • Lymph node status after neoadjuvant therapy (ypN staging)

    Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment

  • DFS

    up to 2 years

  • +3 more secondary outcomes

Study Arms (1)

Arm 1

EXPERIMENTAL

Radiotherapy and Apatinib and Camrelizumab and S-1 and Oxaliplatin

Drug: Apatinib+Camrelizumab+SOXRadiation: Preoperative Radiotherapy

Interventions

Apatinib+Camrelizumab+SOXDRUG

Apatinib 250mg+Camrelizumab 200mg +S-1, Oxaliplatin, q3w

Arm 1
Preoperative RadiotherapyRADIATION

Radiotherapy was administered using IMPT or IMRT. The target volume includes the gastric lesion, and regional lymph nodes. A regimen of 41.4 Gy in 23 fractions is preferred.

Arm 1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0;
  • Plans to proceed to surgery following pre-operative chemotherapy. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
  • Has adequate organ function.
  • Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
  • Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
  • Has life expectancy of greater than 12 months.

You may not qualify if:

  • Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
  • Known hypersensitivity to any of the study drugs or excipients.
  • Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
  • Congenital or acquired immune deficiency (e.g. HIV infected)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (1)

  • Li C, Tian Y, Zheng Y, Yuan F, Shi Z, Yang L, Chen H, Jiang L, Wang X, Zhao P, Zhang B, Wang Z, Zhao Q, Dong J, Lian C, Xu S, Zhang A, Zheng Z, Wang K, Dang C, Wu D, Chen J, Xue Y, Liang B, Cheng X, Wang Q, Chen L, Xia T, Liu H, Xu D, Zhuang J, Wu T, Zhao X, Wu W, Wang H, Peng J, Hou Z, Zheng R, Chen Y, Yin K, Zhu Z. Pathologic Response of Phase III Study: Perioperative Camrelizumab Plus Rivoceranib and Chemotherapy Versus Chemotherapy for Locally Advanced Gastric Cancer (DRAGON IV/CAP 05). J Clin Oncol. 2025 Feb;43(4):464-474. doi: 10.1200/JCO.24.00795. Epub 2024 Oct 9.

    PMID: 39383487RESULT

MeSH Terms

Conditions

Adenocarcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Shu-Bei Wang, MD

CONTACT

+86-021-64370045wangshubei@163.com

Gang Cai, MD

CONTACT

+86-021-64370045cg11855@rjh.com.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2025

First Posted

June 18, 2025

Study Start

June 8, 2025

Primary Completion

September 1, 2025

Study Completion (Estimated)

May 31, 2030

Last Updated

June 18, 2025

Record last verified: 2025-06

Locations

CN(1)