The Necessity of Surgery in Patients With mGC Achieving Radiological Response After Conversion Therapy

NCT07757165 | Recruiting Phase 2

• 1 other identifier: ESMGC
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The core of this study lies in directly addressing the most pressing clinical uncertainty in the current field: For patients with advanced metastatic gastric cancer who have achieved significant radiological remission after conversion therapy, should the addition of radical surgical intervention on top of the best medical treatment bring clear survival benefits to these patients? Answering this question is of extreme importance and urgency, directly affecting the treatment decisions, quality of life, and survival outcomes of a large number of patients.

Conditions

Advanced Metastatic Gastric Cancer

Keywords

Advanced metastatic gastric cancer; Conversion therapy; Radiological response; Surgery

Outcome Measures

Primary Outcomes (1)

• 2-year PFS

  Two-year progression-free survival rate

  2 year

Secondary Outcomes (2)

• 2-year OS

  2 year

• The R0 resection rate

  2 year

Study Arms (2)

The surgical group

EXPERIMENTAL

Surgical radical resection (primary lesion + metastatic lesion) + postoperative adjuvant therapy

Procedure: Surgical radical resection (primary lesion + metastatic lesion)

The non-surgical group

EXPERIMENTAL

Without surgery, continue with the original medical treatment plan until the disease progresses or intolerable toxicity occurs.

Drug: Without surgery, continuing with the original medical treatment

Interventions

Surgical radical resection (primary lesion + metastatic lesion) PROCEDURE

Surgical radical resection (primary lesion + metastatic lesion)

The surgical group

Without surgery, continuing with the original medical treatment DRUG

Without surgery, continue with the original medical treatment plan until the disease progresses or intolerable toxicity occurs.

The non-surgical group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age and Informed Consent: The age range is 18 to 75 years (inclusive), and the participant must voluntarily participate in this study and sign the patient informed consent approved by the ethics committee.
• Pathological Diagnosis: Gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed by histological or cytological examination.
• Disease Staging: Newly diagnosed, unresectable stage IV disease (according to the 8th edition of the AJCC staging system), confirmed by the multidisciplinary team (MDT) of the research center to be unable to undergo radical surgical resection. The types of metastasis include but are not limited to: unresectable distant lymph node metastasis (such as beyond the abdominal aorta trunk, supraclavicular lymph nodes, etc.); distant organ metastasis (such as liver, lungs, peritoneum, ovaries, etc.).
• Conversion Therapy and Efficacy:
• Has received 4-6 cycles of first-line standard conversion therapy. The treatment plan should be based on the latest clinical guidelines and molecular typing (such as fluorouracil/platinum double or triple drug chemotherapy, combined with anti-HER2 treatment (for HER2-positive patients) or immune checkpoint inhibitors (PD-1/PD-L1 inhibitors, such as when CPS ≥ 5 or MSI-H, etc.).
• After conversion therapy, according to the RECIST 1.1 standard, confirmed by the independent imaging assessment committee (IRC) or at least two senior radiologists, the efficacy reaches complete response (CR) or partial response (PR).
• Surgical Feasibility Assessment: Re-evaluated by the MDT of the research center (must include senior gastrointestinal surgeons, oncologists, and radiologists), it is considered that all known lesions (primary and metastatic lesions) can be technically achieved R0 resection, and the patient is expected to be safely and tolerably able to undergo surgery.
• Physical Condition: Eastern Cooperative Oncology Group (ECOG) performance status score (PS) of 0 or 1.
• Good Organ Function (measured within 14 days before randomization), meeting the following laboratory test value standards:
• Hematological System:
• Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L Platelet count (PLT) ≥ 100 × 10⁹/L Hemoglobin (Hb) ≥ 90 g/L
• Liver Function:
• Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (if liver metastasis, then ≤ 5 × ULN)
• Renal Function:
• Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate (Ccr) ≥ 50 mL/min (Cockcroft-Gault formula)

You may not qualify if:

• Pathological type: Other pathological types, such as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, gastrointestinal stromal tumor (GIST), etc.
• Treatment and efficacy:
• During the conversion therapy, disease progression (PD) was confirmed after assessment.
• Previously received systemic anti-tumor treatment for advanced gastric cancer (except for conversion therapy).
• Previously received radical radiotherapy for the stomach or metastatic lesions.
• Surgical contraindications:
• According to MDT assessment, there are residual lesions that cannot be surgically removed (such as diffuse peritoneal metastasis that cannot achieve satisfactory tumor reduction, extensive liver metastasis that cannot preserve sufficient functional liver tissue, etc.).
• There are severe internal medical comorbidities that significantly affect surgical safety, and the anesthesiology and surgical physicians have evaluated that the surgical risk is extremely high, for example:
• Uncontrolled heart failure (NYHA cardiac function class III-IV), unstable angina or myocardial infarction within 6 months.
• Severe chronic obstructive pulmonary disease (COPD) or other severe respiratory diseases, which are expected to be intolerant to general anesthesia.
• Uncontrollable severe infection.
• Past and coexisting disease history:
• In the past 5 years, had other active malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ, etc.
• Had any uncontrolled severe clinical problems (such as severe mental or neurological diseases) that affected the compliance with the protocol or interfered with the interpretation of the research results.
• Laboratory test abnormalities: Any serious and uncontrolled laboratory test abnormalities were found. The investigator considered that participating in this study would bring significant risks.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

RECRUITING

Related Publications (3)

• Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, Wyrwicz L, Yamaguchi K, Skoczylas T, Campos Bragagnoli A, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021 Jul 3;398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2. Epub 2021 Jun 5.

  PMID: 34102137 RESULT

• Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.

  PMID: 20728210 RESULT

• Smyth EC, Nilsson M, Grabsch HI, van Grieken NC, Lordick F. Gastric cancer. Lancet. 2020 Aug 29;396(10251):635-648. doi: 10.1016/S0140-6736(20)31288-5.

  PMID: 32861308 RESULT

MeSH Terms

Interventions

Surgical Procedures, Operative

Central Study Contacts

Xu Dazhi Director of Gastric Surgery Department, Doctoral candidate

CONTACT

+8618121299796; xudzh@shca.org.cn

Yang Han, Doctoral candidate

CONTACT

+8618121299599; hanyang0811@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastric Surgery Department

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 11, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2030
• Last Updated: August 11, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)